FDA Product Code
FDA Product Code BYI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.5665
510(k) Clearances — 58 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252849 | AffloVest® Mobile Airway Clearance Therapy | Tactile Medical | 2026-04-30 | Traditional | PDF ↗ |
| K250860 | BreatheBand® (Model 1000) | Exemplar Medical, LLC | 2025-10-02 | Traditional | PDF ↗ |
| K242063 | LibAirty Airway Clearance System | Synchrony Medical , Ltd. | 2024-12-19 | Traditional | PDF ↗ |
| K240959 | Respiratory Muscle Trainer | Chongqing Moffy Innovation Technology Co., Ltd. | 2024-12-18 | Traditional | PDF ↗ |
| K233441 | The Vest APX System (PVAPX1) | Baxter Healthcare Corportation | 2024-03-22 | Traditional | PDF ↗ |
| K222496 | Electromed SmartVest Airway Clearance System | Electromed, Inc. | 2022-11-18 | Special | PDF ↗ |
| K201490 | Electro Flo 6 Airway Clearance System | Med Systems, Inc. | 2021-02-12 | Traditional | PDF ↗ |
| K203209 | AirPhysio Positive Expiratory Pressure (PEP) Device | Airphysio Pty, Ltd. | 2021-01-15 | Traditional | PDF ↗ |
| K173603 | Monarch Airway Clearance System | Hill-Rom Holdings, Inc. | 2018-10-24 | Traditional | PDF ↗ |
| K163378 | Monarch Airway Clearance System | Hill-Rom Services Pte, Ltd. | 2017-03-17 | Traditional | PDF ↗ |
| K142482 | The Vest Airway Clearance System | Hill-Rom Services Private Limited | 2015-05-07 | Traditional | PDF ↗ |
| K132794 | SMARTVEST AIRWAY CLEARANCE SYSTEM | Electromed, Inc. | 2013-12-19 | Special | PDF ↗ |
| K121587 | BREATH SHAKE | Cheen Houng Ent. Co. , Ltd. | 2013-11-22 | Traditional | PDF ↗ |
| K122480 | INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST | International Biophysics Corporation | 2013-03-27 | Traditional | PDF ↗ |
| K121170 | RESIN 11 | Respinnovation Sas | 2012-07-13 | Traditional | PDF ↗ |
| K103176 | FREQUENCER | Dymedso, Inc. | 2011-01-26 | Traditional | PDF ↗ |
| K100749 | FREQUENCER MODEL V2X | Dymedso, Inc. | 2010-08-31 | Traditional | PDF ↗ |
| K063645 | FREQUENCER, MODEL 1001 | Dymedso, Inc. | 2007-03-15 | Traditional | PDF ↗ |
| K060439 | LUNG FLUTE | Medical Acoustics, LLC | 2006-06-22 | Traditional | PDF ↗ |
| K053248 | SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL | Electromed, Inc. | 2005-12-01 | Traditional | PDF ↗ |
| K051383 | THE INCOURAGE SYSTEM | Respiratory Technologies, Incorporated | 2005-06-17 | Traditional | PDF ↗ |
| K040367 | MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ | Electromed, Inc. | 2004-04-07 | Special | PDF ↗ |
| K031876 | ELECTRO FLO PERCUSSOR, MODEL 5000 | Med Systems | 2003-11-21 | Traditional | PDF ↗ |
| K024309 | THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104 | Advanced Respiratory | 2003-02-21 | Traditional | PDF ↗ |
| K012928 | ABI VEST AIRWAY CLEARANCE SYSTEM | Advanced Respiratory | 2001-10-09 | Traditional | PDF ↗ |
| K993629 | ABI VEST AIRWAY CLEARANCE SYSTEM | American Biosystems, Inc. | 2000-01-21 | Traditional | PDF ↗ |
| K982889 | MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000 | Electromed, Inc. | 1999-06-01 | Traditional | PDF ↗ |
| K974849 | X-AIR-CISER | Hougen Mfg., Inc. | 1998-08-06 | Traditional | PDF ↗ |
| K972859 | FLUTTER D | Bradstreet Clinical Research Assoc., Inc. | 1998-06-05 | Traditional | PDF ↗ |
| K965192 | THAIRAPY VEST SYSTEM | American Biosystems, Inc. | 1997-06-24 | Traditional | PDF ↗ |
| K946083 | FLUTTER(R) | Bradstreet Clinical Research Assoc., Inc. | 1995-03-13 | Traditional | PDF ↗ |
| K931988 | 3P (PULMONARY PERCUSSIVE PACK) | Delta Medical Manuf, Inc. | 1994-10-28 | Traditional | PDF ↗ |
| K936121 | THAIRAPY SYSTEM | American Biosystems, Inc. | 1994-08-02 | Traditional | PDF ↗ |
| K940986 | FLUTTER(R) | Varioraw SA | 1994-05-24 | Traditional | PDF ↗ |
| K913014 | EMS PERCUSSOR | Engineered Medical Systems | 1991-10-23 | Traditional | PDF ↗ |
| K901026 | MJ PERCUSSOR(TM) | Merced Medical, Inc. | 1990-03-15 | Traditional | PDF ↗ |
| K892862 | FLEX-CUP PERCUSSOR | Life Design Systems, Inc. | 1989-05-25 | Traditional | PDF ↗ |
| K882604 | PULMO-PATTY | Tower Stopper, Inc. | 1989-01-04 | Traditional | PDF ↗ |
| K884098 | THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101 | American Biosystems, Inc. | 1988-12-16 | Traditional | PDF ↗ |
| K883899 | MANUAL PERCUSSOR CUPS | Medical Components, Inc. | 1988-12-13 | Traditional | PDF ↗ |
| K880597 | THUMPER MODEL P-1000 | Micro Tek Engineering | 1988-03-29 | Traditional | PDF ↗ |
| K863658 | SALTER LABS 3000 SERIES PERCUSSORS | Salter Labs | 1986-10-06 | Traditional | PDF ↗ |
| K860510 | NEONATE PERCUSSOR | Ballard Medical Products | 1986-02-20 | Traditional | PDF ↗ |
| K855129 | NEOCUSSOR (MASSAGER, BATTERY) POWERED | General Physiotherapy, Inc. | 1986-01-23 | Traditional | PDF ↗ |
| K853965 | NEOGUARD CHEST PERCUSSOR | Cas Medical Systems, Inc. | 1985-12-03 | Traditional | PDF ↗ |
| K842608 | INFANT PERCUSSOR PA-010 | Alpha Medical Systems | 1984-07-23 | Traditional | PDF ↗ |
| K821265 | PNEUMOPULSSOR (PPS II) | Strom Corp. | 1982-07-26 | Traditional | PDF ↗ |
| K821570 | PNEUMO PULSSOR III | Strom Corp. | 1982-06-03 | Traditional | PDF ↗ |
| K813438 | PNEUMO PULSSOR | Strom Corp. | 1981-12-29 | Traditional | PDF ↗ |
| K812803 | INFANT PERCUSSOR #5534 | Hudson Oxygen Therapy Sales Co. | 1981-12-03 | Traditional | PDF ↗ |
| K812151 | MJ NEONATAL PERCUSSOR | Cussionair Therapy Products, Inc. | 1981-08-25 | Traditional | PDF ↗ |
| K812166 | PERCUSSOR | Dhd Medical Products Div. Diemolding Corp. | 1981-08-18 | Traditional | PDF ↗ |
| K802646 | HAND PERCUSSOR CUP #65210 | B & F Medical Products, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K802399 | MODEL 2500 PNEUMATIC PERCUSSOR | Medical Equipment Development Co., Inc. | 1980-10-23 | Traditional | PDF ↗ |
| K801982 | THE MCSHIRLEY PERCUSSOR | Mcshirley Products, Inc. | 1980-09-16 | Traditional | PDF ↗ |
| K800713 | MJ PERCUSSOR | Cussionair Therapy Products, Inc. | 1980-04-10 | Traditional | PDF ↗ |
| K790675 | 5300 PERCUSSOR | Hudson Oxygen Therapy Sales Co. | 1979-04-18 | Traditional | PDF ↗ |
| K771876 | ARGYLE PEOCUSSOR SYSTEM | Sherwood Medical Industries | 1977-10-28 | Traditional | PDF ↗ |
Product code BYI · Class II · Anesthesiology. Data: openFDA.