Panels › Anesthesiology › Product code BYI · Class 2
Percussor, Powered-Electric
Regulation 868.5665
1510(k)s in 12 months (58 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in BYI
| Company | 510(k)s | Recalls |
|---|---|---|
| Electromed, Inc. | 5 | 0 |
| American Biosystems, Inc. | 4 | 0 |
| Dymedso, Inc. | 3 | 0 |
| Strom Corp. | 3 | 0 |
| Advanced Respiratory | 2 | 0 |
| Bradstreet Clinical Research Assoc., Inc. | 2 | 0 |
| Cussionair Therapy Products, Inc. | 2 | 0 |
| Hudson Oxygen Therapy Sales Co. | 2 | 0 |
| Med Systems | 2 | 0 |
| Airphysio Pty, Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 30, 2026 | K252849 | AffloVest® Mobile Airway Clearance Therapy Tactile Medical | BYI |
| Oct 2, 2025 | K250860 | BreatheBand® (Model 1000) Exemplar Medical, LLC | BYI |
| Dec 19, 2024 | K242063 | LibAirty Airway Clearance System Synchrony Medical , Ltd., IL | BYI |
| Dec 18, 2024 | K240959 | Respiratory Muscle Trainer Chongqing Moffy Innovation Technology Co., Ltd., CN | BYI |
| Mar 22, 2024 | K233441 | The Vest APX System (PVAPX1) Baxter Healthcare Corportation | BYI |
| Nov 18, 2022 | K222496 | Electromed SmartVest Airway Clearance System Electromed, Inc. | BYI |
| Feb 12, 2021 | K201490 | Electro Flo 6 Airway Clearance System Med Systems, Inc. | BYI |
| Jan 15, 2021 | K203209 | AirPhysio Positive Expiratory Pressure (PEP) Device Airphysio Pty, Ltd., AU | BYI |
| Oct 24, 2018 | K173603 | Monarch Airway Clearance System Hill-Rom Holdings, Inc., SG | BYI |
| Mar 17, 2017 | K163378 | Monarch Airway Clearance System Hill-Rom Services Pte, Ltd., SG | BYI |
| May 7, 2015 | K142482 | The Vest Airway Clearance System Hill-Rom Services Private Limited, SG | BYI |
| Dec 19, 2013 | K132794 | SMARTVEST AIRWAY CLEARANCE SYSTEM Electromed, Inc. | BYI |
| Nov 22, 2013 | K121587 | BREATH SHAKE Cheen Houng Ent. Co. , Ltd. | BYI |
| Mar 27, 2013 | K122480 | INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST International Biophysics Corporation | BYI |
| Jul 13, 2012 | K121170 | RESIN 11 Respinnovation Sas | BYI |
| Jan 26, 2011 | K103176 | FREQUENCER Dymedso, Inc. | BYI |
| Aug 31, 2010 | K100749 | FREQUENCER MODEL V2X Dymedso, Inc. | BYI |
| Mar 15, 2007 | K063645 | FREQUENCER, MODEL 1001 Dymedso, Inc. | BYI |
| Jun 22, 2006 | K060439 | LUNG FLUTE Medical Acoustics, LLC | BYI |
| Dec 1, 2005 | K053248 | SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL Electromed, Inc. | BYI |
| Jun 17, 2005 | K051383 | THE INCOURAGE SYSTEM Respiratory Technologies, Incorporated | BYI |
| Apr 7, 2004 | K040367 | MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ Electromed, Inc. | BYI |
| Nov 21, 2003 | K031876 | ELECTRO FLO PERCUSSOR, MODEL 5000 Med Systems | BYI |
| Feb 21, 2003 | K024309 | THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104 Advanced Respiratory | BYI |
| Oct 9, 2001 | K012928 | ABI VEST AIRWAY CLEARANCE SYSTEM Advanced Respiratory | BYI |
| Jan 21, 2000 | K993629 | ABI VEST AIRWAY CLEARANCE SYSTEM American Biosystems, Inc. | BYI |
| Jun 1, 1999 | K982889 | MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000 Electromed, Inc. | BYI |
| Aug 6, 1998 | K974849 | X-AIR-CISER Hougen Mfg., Inc. | BYI |
| Jun 5, 1998 | K972859 | FLUTTER D Bradstreet Clinical Research Assoc., Inc. | BYI |
| Jun 24, 1997 | K965192 | THAIRAPY VEST SYSTEM American Biosystems, Inc. | BYI |
| Mar 13, 1995 | K946083 | FLUTTER(R) Bradstreet Clinical Research Assoc., Inc. | BYI |
| Oct 28, 1994 | K931988 | 3P (PULMONARY PERCUSSIVE PACK) Delta Medical Manuf, Inc. | BYI |
| Aug 2, 1994 | K936121 | THAIRAPY SYSTEM American Biosystems, Inc. | BYI |
| May 24, 1994 | K940986 | FLUTTER(R) Varioraw SA | BYI |
| Oct 23, 1991 | K913014 | EMS PERCUSSOR Engineered Medical Systems | BYI |
| Mar 15, 1990 | K901026 | MJ PERCUSSOR(TM) Merced Medical, Inc. | BYI |
| May 25, 1989 | K892862 | FLEX-CUP PERCUSSOR Life Design Systems, Inc. | BYI |
| Jan 4, 1989 | K882604 | PULMO-PATTY Tower Stopper, Inc. | BYI |
| Dec 16, 1988 | K884098 | THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101 American Biosystems, Inc. | BYI |
| Dec 13, 1988 | K883899 | MANUAL PERCUSSOR CUPS Medical Components, Inc. | BYI |
| Mar 29, 1988 | K880597 | THUMPER MODEL P-1000 Micro Tek Engineering | BYI |
| Oct 6, 1986 | K863658 | SALTER LABS 3000 SERIES PERCUSSORS Salter Labs | BYI |
| Feb 20, 1986 | K860510 | NEONATE PERCUSSOR Ballard Medical Products | BYI |
| Jan 23, 1986 | K855129 | NEOCUSSOR (MASSAGER, BATTERY) POWERED General Physiotherapy, Inc. | BYI |
| Dec 3, 1985 | K853965 | NEOGUARD CHEST PERCUSSOR Cas Medical Systems, Inc. | BYI |
| Jul 23, 1984 | K842608 | INFANT PERCUSSOR PA-010 Alpha Medical Systems | BYI |
| Jul 26, 1982 | K821265 | PNEUMOPULSSOR (PPS II) Strom Corp. | BYI |
| Jun 3, 1982 | K821570 | PNEUMO PULSSOR III Strom Corp. | BYI |
| Dec 29, 1981 | K813438 | PNEUMO PULSSOR Strom Corp. | BYI |
| Dec 3, 1981 | K812803 | INFANT PERCUSSOR #5534 Hudson Oxygen Therapy Sales Co. | BYI |
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