FDA Product Code
FDA Product Code BTO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.5800
510(k) Clearances — 129 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253063 | Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) | Vitaltec Corporation | 2026-09-11 | Special | PDF ↗ |
| K242921 | 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm | Vitaltec Corporation | 2025-06-10 | Traditional | PDF ↗ |
| K233713 | Pilling Tracheostomy Tubes | Teleflex Medical | 2024-03-22 | Traditional | PDF ↗ |
| K192511 | Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 9.0 mm | Venner Medical (Singapore) Pte, Ltd. | 2020-07-22 | Traditional | PDF ↗ |
| K173384 | BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube | Smiths Medical Ads, Inc. | 2018-04-10 | Traditional | PDF ↗ |
| K120079 | PRIMED TRACHEOSTOMY TUBES (MULTIPLE) | Primed Halberstadt Medizintechnik GmbH | 2012-05-24 | Traditional | PDF ↗ |
| K101721 | WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA | Regulatory and Marketing Services, Inc. | 2011-03-24 | Special | PDF ↗ |
| K100950 | VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE | Venner Medical (Singapore) Pte, Ltd. | 2010-07-13 | Traditional | PDF ↗ |
| K100480 | ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH | Vitaltec Corporation | 2010-06-11 | Traditional | PDF ↗ |
| K100283 | VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC | Cook, Inc. | 2010-04-23 | Traditional | PDF ↗ |
| K083031 | PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT | Smiths Medical Asd, Inc. | 2009-08-18 | Traditional | PDF ↗ |
| K073702 | PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR | Lazarus Medical, LLC | 2008-06-26 | Traditional | PDF ↗ |
| K062104 | TALKING TRACH | Engineered Medical Systems, Inc. | 2007-04-20 | Traditional | PDF ↗ |
| K060945 | PORTEX PERCUTANEOUS TRACHEOSTOMY KIT | Smiths Medical International | 2006-06-19 | Traditional | PDF ↗ |
| K051587 | TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 | Tracoe Medical GmbH | 2005-10-25 | Traditional | PDF ↗ |
| K050379 | CS MEDICAL ADULT TTCF CATHETER | Cs Medical, Inc. | 2005-07-12 | Traditional | PDF ↗ |
| K042684 | WELL LEAD TRACHEOSTOMY TUBE | Well Lead Medical Instruments | 2005-02-17 | Traditional | PDF ↗ |
| K031553 | SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES | Arcadia Medical Corporation | 2003-11-18 | Traditional | PDF ↗ |
| K030570 | BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE | Portex , Ltd. | 2003-09-17 | Traditional | PDF ↗ |
| K030381 | PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA | Portex , Ltd. | 2003-08-27 | Traditional | PDF ↗ |
| K021764 | RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED | Rusch Intl. | 2002-07-23 | Traditional | PDF ↗ |
| K983000 | CRICOTHYROTOMY TUBE | Polamedco, Inc. | 1999-10-27 | Traditional | PDF ↗ |
| K981080 | SCOOP 1 | Transtracheal Systems | 1998-06-17 | Traditional | PDF ↗ |
| K955461 | TRANSTRACHEAL CATHETER (ACC. RAVUSSIN). | VBM Medizintechnik GmbH | 1997-03-19 | Traditional | PDF ↗ |
| K960205 | CPR TRACHEOTOMY CARE TRAY | Custom Pack Reliability | 1996-08-27 | Traditional | PDF ↗ |
| K962240 | MOORE TRACHEOSTOMY TUBE | Boston Medical Products, Inc. | 1996-08-15 | Traditional | PDF ↗ |
| K953559 | LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION) | Seidel Medizin GmbH | 1996-05-16 | Traditional | PDF ↗ |
| K952416 | TRACHEOSTOMY CARE KIT | Medi-Flex Hospital Products, Inc. | 1995-08-09 | Traditional | PDF ↗ |
| K945407 | SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT | Mallinckrodt Medical Tpi, Inc. | 1995-02-27 | Traditional | PDF ↗ |
| K945406 | SSV PHONATE(TM) SHILEY SPEAKING VALVE | Mallinckrodt Medical Tpi, Inc. | 1995-02-27 | Traditional | PDF ↗ |
| K941470 | TRACHEOSTOMY CARE KIT | Clinical Resources, Inc. | 1995-02-14 | Traditional | PDF ↗ |
| K924193 | TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685) | American Healthcare Corp. | 1993-06-16 | Traditional | PDF ↗ |
| K924191 | TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL | American Healthcare Corp. | 1993-04-02 | Traditional | PDF ↗ |
| K924195 | TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES | American Healthcare Corp. | 1993-01-06 | Traditional | PDF ↗ |
| K924194 | TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686) | American Healthcare Corp. | 1993-01-06 | Traditional | PDF ↗ |
| K923834 | TRACHEOSTOMY CARE SET WITH GLOVES | American Healthcare Corp. | 1992-12-10 | Traditional | PDF ↗ |
| K925249 | CMI STOMA COVERS | Community Medical Center | 1992-12-03 | Traditional | PDF ↗ |
| K922749 | LOW PROFILE TRACHEOSTOMY TUBE | Concord/Portex | 1992-09-02 | Traditional | PDF ↗ |
| K920281 | TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE | Trinity Laboratories, Inc. | 1992-08-27 | Traditional | PDF ↗ |
| K921281 | TRACHEOSTOMY CARE KIT | Trinity Laboratories, Inc. | 1992-08-27 | Traditional | PDF ↗ |
| K920604 | BIVONA TRACHEAL T-TUBE STENT | Bivona Medical Technologies | 1992-07-27 | Traditional | PDF ↗ |
| K914743 | EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF | Pertrach | 1992-07-10 | Traditional | PDF ↗ |
| K912124 | TRACHEOSTOMY TUBE AND CUFF | Concord/Portex | 1991-08-16 | Traditional | PDF ↗ |
| K912469 | BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE | Bivona Medical Technologies | 1991-06-19 | Traditional | PDF ↗ |
| K903730 | D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES | Concord/Portex | 1990-09-25 | Traditional | PDF ↗ |
| K901920 | PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE | Primecare, Inc. | 1990-08-17 | Traditional | PDF ↗ |
| K902281 | MODIFIED SCOOP TRANSTRACHEAL CATHETERS | Transtracheal Systems | 1990-08-10 | Traditional | PDF ↗ |
| K901078 | SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE | L H M Ent., Inc. | 1990-05-18 | Traditional | PDF ↗ |
| K901079 | SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER | L H M Ent., Inc. | 1990-05-18 | Traditional | PDF ↗ |
| K900548 | SHILEY PHONATION VALVE | Shiley, Inc. | 1990-04-23 | Traditional | PDF ↗ |
| K894096 | STAT-TRACH(TM) VENTILATION CATHETER | Statron Corp. | 1990-03-16 | Traditional | PDF ↗ |
| K896798 | TRACHEOSTOMY TRAY | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-22 | Traditional | PDF ↗ |
| K895162 | TRAUMAFUSE TRACH SHIELD | The Traumafuse Co. | 1990-01-09 | Traditional | PDF ↗ |
| K895130 | HEIMLICH MICRO TRACH | Ballard Medical Products | 1989-11-07 | Traditional | PDF ↗ |
| K893866 | HOOD PEDIATRIC TRACHEOSTOMY TUBE | Hood Laboratories | 1989-08-07 | Traditional | PDF ↗ |
| K885139 | MODIFIED ADULT CRICOTHYROIDOTOMY KIT | Pertrach | 1989-05-25 | Traditional | PDF ↗ |
| K890342 | AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES) | Eastmed Enterprises, Inc. | 1989-04-27 | Traditional | PDF ↗ |
| K884730 | SHILEY PERC TRACHEOSTOMY SYSTEM | Shiley, Inc. | 1989-01-17 | Traditional | PDF ↗ |
| K884015 | PREMIER DECANNULATION STOPPER | Premier Dental | 1988-11-03 | Traditional | PDF ↗ |
| K884427 | FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT. | Bivona Medical Technologies | 1988-11-02 | Traditional | PDF ↗ |
| K882430 | HOOD TRACHEAL STOMA BUTTON | Hood Laboratories | 1988-06-28 | Traditional | PDF ↗ |
| K880614 | SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE | Shiley, Inc. | 1988-03-09 | Traditional | PDF ↗ |
| K880317 | PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP | Automatic Liquid Packaging, Inc. | 1988-02-29 | Traditional | PDF ↗ |
| K880316 | PREFILLED WATER FOR IRRIGATION USP | Automatic Liquid Packaging, Inc. | 1988-02-29 | Traditional | PDF ↗ |
| K874450 | SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT | Surgitech C/O Collier, Shannon, Rill & Scott | 1988-02-29 | Traditional | PDF ↗ |
| K880247 | MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES | Shiley, Inc. | 1988-02-12 | Traditional | PDF ↗ |
| K874742 | QUICKTRACH | Posey Co. | 1987-12-31 | Traditional | PDF ↗ |
| K873499 | TODD MEDICAL/SKILLED CARE PRODUCTS | Todd Medical, Inc. | 1987-11-24 | Traditional | PDF ↗ |
| K872486 | LARKEL DEVICE W/ATTACHMENTS A-H | Seidel Medizin GmbH | 1987-09-16 | Traditional | PDF ↗ |
| K871199 | MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO. | Frederic J. Toye, M.D. | 1987-06-08 | Traditional | PDF ↗ |
| K870181 | JOHNSON INTRATRACHEAL OXYGEN CATHETER SET | Cook, Inc. | 1987-05-14 | Traditional | PDF ↗ |
| K865061 | SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE | Shiley, Inc. | 1987-01-15 | Traditional | PDF ↗ |
| K862436 | TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN) | Acutronic Medical Systems AG | 1986-11-03 | Traditional | PDF ↗ |
| K862909 | RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM | Intl. Medical Devices , Ltd. | 1986-09-09 | Traditional | PDF ↗ |
| K862167 | MINI-TRACH KIT | Portex, Inc. | 1986-08-06 | Traditional | PDF ↗ |
| K862267 | FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES | Bivona Medical Technologies | 1986-06-18 | Traditional | PDF ↗ |
| K861645 | MICRO-TRACHEOSTOMY CARE KIT | Aci Medical, Inc. | 1986-05-09 | Traditional | PDF ↗ |
| K853051 | TRACHEAL TUBES | Erie Medical | 1986-04-11 | Traditional | PDF ↗ |
| K855130 | TRACHEOSTOMY CARE KIT | Dynarex Corp. | 1986-03-04 | Traditional | PDF ↗ |
| K854252 | TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER | Transtracheal Systems | 1986-02-03 | Traditional | PDF ↗ |
| K860176 | LARYNGECTOMY TUBE, CUFFED | Sheridan Catheter Corp. | 1986-01-27 | Traditional | PDF ↗ |
| K853511 | THE HOOD LIFE SAVER | Hood Laboratories | 1985-12-19 | Traditional | PDF ↗ |
| K853419 | CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE | Hood Laboratories | 1985-12-06 | Traditional | PDF ↗ |
| K852413 | LGT TUBE | Mallinckrodt Critical Care | 1985-09-05 | Traditional | PDF ↗ |
| K852272 | BIVONA TRACHEOSTOMA VALVE II | Bivona Medical Technologies | 1985-07-08 | Traditional | PDF ↗ |
| K851016 | PASSY-MUIR TRACH VALVE | Passy & Passy, Inc. | 1985-06-07 | Traditional | PDF ↗ |
| K851462 | BFW VOICE GENERATOR | Bfw Laboratories, Inc. | 1985-05-28 | Traditional | PDF ↗ |
| K850445 | TRACHEOSTOMY CARE TRAY | Paco Research Corp. | 1985-03-11 | Traditional | PDF ↗ |
| K850446 | TRACHEOSTOMY CARE KIT | Paco Research Corp. | 1985-03-11 | Traditional | PDF ↗ |
| K850456 | TRACHEOSTOMY CARE KIT | Excel Health Care Products | 1985-03-11 | Traditional | PDF ↗ |
| K843785 | WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR | Intl. Medical Devices , Ltd. | 1984-10-23 | Traditional | PDF ↗ |
| K843729 | SHILEY DISPOS. CANNULA FENESTRATED LOW | Shiley, Inc. | 1984-10-19 | Traditional | PDF ↗ |
| K843730 | SHILEY DISPOS. DECANNULATION PLUG W/SW/ | Shiley, Inc. | 1984-10-19 | Traditional | PDF ↗ |
| K822440 | PERCUTANEOUS CRICOTHYROIDOTOMY | Frederic J. Toye, M.D. | 1984-10-15 | Traditional | PDF ↗ |
| K832466 | TRACHEAL TUBE 16 GAUGE-1.65MM- | Erie Medical | 1984-09-19 | Traditional | PDF ↗ |
| K842415 | ALL-HANDS TRACHEOSTOMY CARE SET 0101 | All-Hands Medical Supply, Inc. | 1984-07-06 | Traditional | PDF ↗ |
| K841266 | MONTGOMERY TRACHEAL T-TUBE | E. Benson Hood Laboratories, Inc. | 1984-06-14 | Traditional | PDF ↗ |
| K840925 | PEDIA-TRAKE CRICOTHYROTOMY KIT | Intl. Medical Devices , Ltd. | 1984-05-02 | Traditional | PDF ↗ |
| K841546 | COMMUNI-TRACH TUBE | Implant Technology, Inc. | 1984-04-30 | Traditional | PDF ↗ |
| K833832 | 3-DAY BIOINDICATOR RELEASE FOR RESPIR | Shiley, Inc. | 1984-03-15 | Traditional | PDF ↗ |
Product code BTO · Class II · Anesthesiology. Data: openFDA.