FDA Product Code
FDA Product Code DRS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2850
510(k) Clearances — 149 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254074 | TruPress | Procerus Enterprises | 2026-09-10 | Traditional | PDF ↗ |
| K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | Edwards Lifesciences, LLC | 2025-03-21 | Special | PDF ↗ |
| K221782 | Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes | Merit Medical Pte. , Ltd. | 2023-03-17 | Traditional | PDF ↗ |
| K172458 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit | Smiths Medical Asd, Inc. | 2017-11-09 | Traditional | PDF ↗ |
| K163172 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit | Smiths Medical Asd, Inc. | 2017-05-24 | Traditional | PDF ↗ |
| K161408 | Compass Cast and MAP | Centurion Medical Products Corporation | 2016-11-22 | Traditional | PDF ↗ |
| K152472 | Disposable Pressure Transducer | Zhejiang Haisheng Medical Device Co., Ltd. | 2016-10-31 | Traditional | PDF ↗ |
| K152980 | Flo Trac sensor, Volume View sensor | Edwards Lifesciences, LLC | 2016-01-19 | Traditional | PDF ↗ |
| K151040 | Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer | Biometrix , Ltd. | 2015-09-04 | Traditional | PDF ↗ |
| K133624 | COMPASS CT, COMPASS CT PORT | Mirador Biomedical | 2014-04-18 | Traditional | PDF ↗ |
| K123095 | MEDLINE BLOOD PRESSURE TRANSDUCER | Medline Industries, Inc. | 2013-05-08 | Abbreviated | PDF ↗ |
| K120624 | ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) | Elcam Medical Acal | 2012-06-08 | Traditional | PDF ↗ |
| K112203 | COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST | Mirador Biomedical, Inc. | 2011-12-14 | Traditional | PDF ↗ |
| K102033 | COMBITRANS MONITORING SETS AND ACCESSORIES | B.Braun Melsungen AG | 2011-04-07 | Abbreviated | PDF ↗ |
| K103715 | COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE | Mirador Biomedical, Inc. | 2011-01-20 | Special | PDF ↗ |
| K101189 | REAVILLMED PRESSURE MONITORING SYSTEM AND PICC | Reavillmed | 2010-12-22 | Traditional | PDF ↗ |
| K101518 | COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE | Mirador Biomedical, Inc. | 2010-10-13 | Traditional | PDF ↗ |
| K092644 | TERUMO PRESSURE ISOLATOR | Terumo Cardiovascular Systems Corp. | 2009-12-10 | Traditional | PDF ↗ |
| K091408 | DISPOSABLE PRESSURE TRANSDUCER | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2009-08-18 | Traditional | PDF ↗ |
| K070710 | ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM | Biosensors International-USA | 2007-04-19 | Special | PDF ↗ |
| K062342 | TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT | Sentra Medical Devices, LLC | 2006-09-25 | Traditional | PDF ↗ |
| K061573 | TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT | Hospira, Inc. | 2006-09-19 | Special | PDF ↗ |
| K052828 | DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT) | Hospira, Inc. | 2006-02-17 | Special | PDF ↗ |
| K043065 | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P | Edwards Lifesciences, LLC | 2005-01-26 | Traditional | PDF ↗ |
| K983372 | BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP | Sunscope Intl., Inc. | 1999-02-05 | Traditional | PDF ↗ |
| K981747 | BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX | Sunscope Intl., Inc. | 1998-08-20 | Traditional | PDF ↗ |
| K981745 | BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX | Sunscope Intl., Inc. | 1998-07-17 | Traditional | PDF ↗ |
| K961404 | MX960 REUSABLE PRESSURE TRANSDUCER | Medex, Inc. | 1996-06-27 | Traditional | PDF ↗ |
| K951722 | PERCEPTOR COMPENSATOR MORSE MANIFOLD | Namic | 1996-03-25 | Traditional | PDF ↗ |
| K951129 | NOVATRANS II | Medex, Inc. | 1995-04-05 | Traditional | PDF ↗ |
| K930888 | WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM | Ralin Medical, Inc. | 1993-07-21 | Traditional | PDF ↗ |
| K921343 | COBE PATIENT MONITORING PRODUCTS | Cobe Cardiovascular, Inc. | 1993-01-05 | Traditional | PDF ↗ |
| K920977 | MERITRANS(TM) DISPOSABLE TRANSDUCER | Merit Medical Systems, Inc. | 1992-12-11 | Traditional | PDF ↗ |
| K921898 | TAD MODEL #9655 | Loric Technology | 1992-11-02 | Traditional | PDF ↗ |
| K910764 | THE PERCEPTOR(TM) STAND ALONE TRANSDUCER | North American Instrument Corp. | 1991-04-22 | Traditional | PDF ↗ |
| K904777 | SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS | Baxter Healthcare Corp | 1991-01-15 | Traditional | PDF ↗ |
| K904601 | ADVANCE DISPOSABLE PRESSURE TRANSDUCER | Advance Medical Designs, Inc. | 1990-12-17 | Traditional | PDF ↗ |
| K902472 | MORSE DT MANIFOLD | North American Instrument Corp. | 1990-08-23 | Traditional | PDF ↗ |
| K902453 | OSCILLOMETRIC PULSE DETECTION DEVICE | Thomas J. Fogarty, M.D. | 1990-08-23 | Traditional | PDF ↗ |
| K900551 | MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC. | Matrix Medica, Inc. | 1990-05-09 | Traditional | PDF ↗ |
| K884235 | COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT | Burron Medical, Inc. | 1990-03-06 | Traditional | PDF ↗ |
| K885296 | MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F | Baxter Healthcare Corp | 1989-01-25 | Traditional | PDF ↗ |
| K884919 | DISPOSABLE DOME STOCK #D-300 | Advanced Medical, Inc. | 1989-01-05 | Traditional | PDF ↗ |
| K881297 | BARO-GRAF 24 | Instromedix, Inc. | 1988-09-16 | Traditional | PDF ↗ |
| K883095 | MX860, REUSABLE PRESSURE TRANSDUCER | Medex, Inc. | 1988-09-12 | Traditional | PDF ↗ |
| K882118 | MODEL 700 PATIENT MONITOR | Ivy Biomedical Systems, Inc. | 1988-08-02 | Traditional | PDF ↗ |
| K873168 | SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS | Spectramed, Inc. | 1988-01-12 | Traditional | PDF ↗ |
| K872596 | TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 | American Edwards Laboratories | 1987-09-30 | Traditional | PDF ↗ |
| K870356 | TATCH-IT | Reunion Medical Co. | 1987-06-12 | Traditional | PDF ↗ |
| K871371 | DIGITAL SPHYGMOMANOMETER | Omron Tateisi Electronics Co. | 1987-06-12 | Traditional | PDF ↗ |
| K870301 | MX900-DPT, DISPOSABLE PRESSURE TRANSDUCER | Medex, Inc. | 1987-05-06 | Traditional | PDF ↗ |
| K864090 | SHELF LIFE CHANGE OF STERILE DEVICES | Utah Medical Products, Inc. | 1987-03-20 | Traditional | PDF ↗ |
| K862344 | GOULD XCALIBER | Bio-Tek Instruments, Inc. | 1986-08-06 | Traditional | PDF ↗ |
| K860681 | DISPOSABLE FLUSH DEVICE | Hewlett-Packard Co. | 1986-06-17 | Traditional | PDF ↗ |
| K853996 | DISPOSABLE PRESSURE TRANSDUCER SYSTEM STERILE | Transamerica Delaval, Inc. | 1986-05-07 | Traditional | PDF ↗ |
| K854596 | TDK ECG ELECTRODE MEL-08-09 & -11 | Tdk Corp. | 1986-05-07 | Traditional | PDF ↗ |
| K855145 | MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR | Gould, Inc. | 1986-02-26 | Traditional | PDF ↗ |
| K854505 | CARDIMAX FX-406U | Brentwood Instruments, Inc. | 1986-02-04 | Traditional | PDF ↗ |
| K852652 | OMNIGRAPH 4000(ELECTROCARDIOGRAPH) | Telemed Div. | 1985-11-19 | Traditional | PDF ↗ |
| K841960 | CARDIO METRICS INVASIVE PRESSURE MONIT | Sterile Design, Inc. | 1985-11-08 | Traditional | PDF ↗ |
| K851486 | GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX | Gould, Inc. | 1985-10-17 | Traditional | PDF ↗ |
| K841811 | BENTLEY-TRANTEC DISPOS. DOMES D-260- | American Bentley | 1985-09-09 | Traditional | PDF ↗ |
| K851989 | DOME, DISPOSABLE, STERILE | Transamerica Delaval, Inc. | 1985-08-19 | Traditional | PDF ↗ |
| K851988 | ADMINISTRATION SET | Transamerica Delaval, Inc. | 1985-08-16 | Traditional | PDF ↗ |
| K851987 | FLUSH DEVICE, AUTOMATIC | Transamerica Delaval, Inc. | 1985-08-16 | Traditional | PDF ↗ |
| K851888 | APM DISPOS. BLOOD PRESSURE TRANSDUCER | Honeywell, Inc. | 1985-08-06 | Traditional | PDF ↗ |
| K850898 | MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCER | Medi-Trace Products Division | 1985-07-25 | Traditional | PDF ↗ |
| K843273 | DISPOS. PRESSURE KIT 1295K SERIES | Hewlett-Packard Co. | 1985-06-11 | Traditional | PDF ↗ |
| K843580 | MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO | Graphic Controls Corp. | 1985-05-28 | Traditional | PDF ↗ |
| K841788 | UTAH DISPOSABLE PRESSURE TRANSDUCER | Utah Medical Products, Inc. | 1985-03-25 | Traditional | PDF ↗ |
| K842352 | PRESSURE MONITORING KIT | Utah Medical Products, Inc. | 1985-03-25 | Traditional | PDF ↗ |
| K841613 | PRESSURE TRANSDUCER DOME 1295C | Hewlett-Packard Co. | 1984-10-24 | Traditional | PDF ↗ |
| K833171 | MONITORING KIT | Transamerica Delaval, Inc. | 1984-09-06 | Traditional | PDF ↗ |
| K833170 | FLUSH DEVICE | Transamerica Delaval, Inc. | 1984-08-12 | Traditional | PDF ↗ |
| K841968 | DESERET DISPOSABLE PRESSURE TRANSDUCER | Parke-Davis Co. | 1984-08-06 | Traditional | PDF ↗ |
| K840023 | TRANTEC PHYSIOLOGICAL PRESSURE TRANSDUC | American Bentley | 1984-06-22 | Traditional | PDF ↗ |
| K840121 | PHYSIOLOGICAL PRESSURE TRANSDUCER 1290C | Hewlett-Packard Co. | 1984-05-16 | Traditional | PDF ↗ |
| K840274 | CARDIOFAX ECG 6543 | Nihon Kohden America, Inc. | 1984-04-17 | Traditional | PDF ↗ |
| K832897 | MODEL TTPM TIME TEMP. PRESSURE MONITOR | Electromedics, Inc. | 1984-03-22 | Traditional | PDF ↗ |
| K833792 | TRANTECSILICONE QUARTZ DISP. TRANSD | American Bentley | 1984-02-10 | Traditional | PDF ↗ |
| K832907 | INVASIVE MONITORING KITS | American Pharmaseal Div. Ahsc | 1984-01-10 | Traditional | PDF ↗ |
| K833271 | NAMIC CONTINUOUS FLUSH DEVICE | North American Instrument Corp. | 1983-12-01 | Traditional | PDF ↗ |
| K832657 | DISPOSABLE MANIFOLD SET | Mallinckrodt Critical Care | 1983-11-07 | Traditional | PDF ↗ |
| K833096 | TRANSDUCER DOME DS106 | Sorensen Research | 1983-11-03 | Traditional | PDF ↗ |
| K833095 | TRANSDUCER DOME SD105 | Sorensen Research | 1983-11-03 | Traditional | PDF ↗ |
| K833094 | TRANSDUCER DOME SD104 | Sorensen Research | 1983-11-03 | Traditional | PDF ↗ |
| K831506 | DISP. TRANSDUCER W/MONITORING KIT TRANS | Sorensen Research | 1983-08-12 | Traditional | PDF ↗ |
| K831867 | PRESSURE MONITORING IV BOTTLE CAP | Alto Development Corp. | 1983-08-12 | Traditional | PDF ↗ |
| K831698 | DISPOSABLE PRESSURE TRANSDUCER#14004195 | Norton Performance Plastics Corp. | 1983-08-11 | Traditional | PDF ↗ |
| K831348 | FLUID ADMIN. SET AFS-1C | Linton Biomed Corp. | 1983-05-27 | Traditional | PDF ↗ |
| K830210 | DISPOSABLE PRESSURE TRANSDUCER | American Pharmaseal Div. Ahsc | 1983-04-18 | Traditional | PDF ↗ |
| K823334 | PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630 | Psitron | 1983-03-24 | Traditional | PDF ↗ |
| K830093 | USCI ELECTRONIC MANOMETER | C.R. Bard, Inc. | 1983-01-28 | Traditional | PDF ↗ |
| K823286 | MODELS DPT 1000/DPT 1000NS | Bio-Med Corp. | 1982-12-30 | Traditional | PDF ↗ |
| K822507 | DISPOSABLE TRANSDUCER & ACCESSORIES | Gould, Inc. | 1982-09-14 | Traditional | PDF ↗ |
| K821894 | DISPOSABLE TRANSDUCER DOMES & KITS | American Pharmaseal Div. Ahsc | 1982-07-20 | Traditional | PDF ↗ |
| K821416 | DISPOSABLE BLOOD PRESSURE TRANSDUCER | Bentley Laboratories, Inc. | 1982-07-02 | Traditional | PDF ↗ |
| K820459 | VIRAGARD/VIRASHIELD | Tri-Med, Inc. | 1982-06-16 | Traditional | PDF ↗ |
| K821450 | PRESSURE TUBING-ADULT & PEDIATRIC | Gould, Inc. | 1982-05-25 | Traditional | PDF ↗ |
| K820579 | FLEX-E1 ECG ELECTRODE | Conmedcorp | 1982-04-14 | Traditional | PDF ↗ |
Product code DRS · Class II · Cardiovascular. Data: openFDA.