Atlas FDA

BYI

58 FDA 510(k) clearances · Product code

87 daysmedian time to decision
254 days90th percentile
58clearances measured

FDA profile

Official device name
Percussor, Powered-Electric
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5665
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2014: 10 · 2021: 15 · 2022: 16 · 2024: 19 · 2025: 39 · 2026: 35
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
AffloVest® Mobile Airway Clearance Therapy (K252849)Tactile Medical2026-04-30
BreatheBand® (Model 1000) (K250860)Exemplar Medical, LLC2025-10-02
LibAirty Airway Clearance System (K242063)Synchrony Medical , Ltd.2024-12-19
Respiratory Muscle Trainer (K240959)Chongqing Moffy Innovation Technology Co., Ltd.2024-12-18
The Vest APX System (PVAPX1) (K233441)Baxter Healthcare Corportation2024-03-22
Electromed SmartVest Airway Clearance System (K222496)Electromed, Inc.2022-11-18
Electro Flo 6 Airway Clearance System (K201490)Med Systems, Inc.2021-02-12
AirPhysio Positive Expiratory Pressure (PEP) Device (K203209)Airphysio Pty, Ltd.2021-01-15
Monarch Airway Clearance System (K173603)Hill-Rom Holdings, Inc.2018-10-24
Monarch Airway Clearance System (K163378)Hill-Rom Services Pte, Ltd.2017-03-17
The Vest Airway Clearance System (K142482)Hill-Rom Services Private Limited2015-05-07
SMARTVEST AIRWAY CLEARANCE SYSTEM (K132794)Electromed, Inc.2013-12-19
BREATH SHAKE (K121587)Cheen Houng Ent. Co. , Ltd.2013-11-22
INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST (K122480)International Biophysics Corporation2013-03-27
RESIN 11 (K121170)Respinnovation Sas2012-07-13
FREQUENCER (K103176)Dymedso, Inc.2011-01-26
FREQUENCER MODEL V2X (K100749)Dymedso, Inc.2010-08-31
FREQUENCER, MODEL 1001 (K063645)Dymedso, Inc.2007-03-15
LUNG FLUTE (K060439)Medical Acoustics, LLC2006-06-22
SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL (K053248)Electromed, Inc.2005-12-01
THE INCOURAGE SYSTEM (K051383)Respiratory Technologies, Incorporated2005-06-17
MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ (K040367)Electromed, Inc.2004-04-07
ELECTRO FLO PERCUSSOR, MODEL 5000 (K031876)Med Systems2003-11-21
THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104 (K024309)Advanced Respiratory2003-02-21
ABI VEST AIRWAY CLEARANCE SYSTEM (K012928)Advanced Respiratory2001-10-09
ABI VEST AIRWAY CLEARANCE SYSTEM (K993629)American Biosystems, Inc.2000-01-21
MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000 (K982889)Electromed, Inc.1999-06-01
X-AIR-CISER (K974849)Hougen Mfg., Inc.1998-08-06
FLUTTER D (K972859)Bradstreet Clinical Research Assoc., Inc.1998-06-05
THAIRAPY VEST SYSTEM (K965192)American Biosystems, Inc.1997-06-24
FLUTTER(R) (K946083)Bradstreet Clinical Research Assoc., Inc.1995-03-13
3P (PULMONARY PERCUSSIVE PACK) (K931988)Delta Medical Manuf, Inc.1994-10-28
THAIRAPY SYSTEM (K936121)American Biosystems, Inc.1994-08-02
FLUTTER(R) (K940986)Varioraw SA1994-05-24
EMS PERCUSSOR (K913014)Engineered Medical Systems1991-10-23
MJ PERCUSSOR(TM) (K901026)Merced Medical, Inc.1990-03-15
FLEX-CUP PERCUSSOR (K892862)Life Design Systems, Inc.1989-05-25
PULMO-PATTY (K882604)Tower Stopper, Inc.1989-01-04
THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101 (K884098)American Biosystems, Inc.1988-12-16
MANUAL PERCUSSOR CUPS (K883899)Medical Components, Inc.1988-12-13
THUMPER MODEL P-1000 (K880597)Micro Tek Engineering1988-03-29
SALTER LABS 3000 SERIES PERCUSSORS (K863658)Salter Labs1986-10-06
NEONATE PERCUSSOR (K860510)Ballard Medical Products1986-02-20
NEOCUSSOR (MASSAGER, BATTERY) POWERED (K855129)General Physiotherapy, Inc.1986-01-23
NEOGUARD CHEST PERCUSSOR (K853965)Cas Medical Systems, Inc.1985-12-03
INFANT PERCUSSOR PA-010 (K842608)Alpha Medical Systems1984-07-23
PNEUMOPULSSOR (PPS II) (K821265)Strom Corp.1982-07-26
PNEUMO PULSSOR III (K821570)Strom Corp.1982-06-03
PNEUMO PULSSOR (K813438)Strom Corp.1981-12-29
INFANT PERCUSSOR #5534 (K812803)Hudson Oxygen Therapy Sales Co.1981-12-03
MJ NEONATAL PERCUSSOR (K812151)Cussionair Therapy Products, Inc.1981-08-25
PERCUSSOR (K812166)Dhd Medical Products Div. Diemolding Corp.1981-08-18
HAND PERCUSSOR CUP #65210 (K802646)B & F Medical Products, Inc.1980-11-12
MODEL 2500 PNEUMATIC PERCUSSOR (K802399)Medical Equipment Development Co., Inc.1980-10-23
THE MCSHIRLEY PERCUSSOR (K801982)Mcshirley Products, Inc.1980-09-16
MJ PERCUSSOR (K800713)Cussionair Therapy Products, Inc.1980-04-10
5300 PERCUSSOR (K790675)Hudson Oxygen Therapy Sales Co.1979-04-18
ARGYLE PEOCUSSOR SYSTEM (K771876)Sherwood Medical Industries1977-10-28

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Every clearance here is in the API, with alerts when new ones post.