Product code BYI— Anesthesiology
ABI VEST AIRWAY CLEARANCE SYSTEM
- Classification name
- Percussor, Powered-Electric
- Device class
- Class 2
- Regulation
- 21 CFR 868.5665
- Advisory panel
- Anesthesiology
- Total cleared
- 58
- First cleared
- Most recent
Market context for product code BYI
FDA has cleared devices under product code BYI between 1977 and 2026, filed by 43 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2022
- 2021
- 2018
- 2017
- 2015
- 2013
- 2012
- 2011
- 2010
- 2007
- 2006
- 2005
Top applicants under product code BYI
Adverse events under product code BYI
product code BYI- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code BYI
- K252849 — AffloVest® Mobile Airway Clearance Therapy
- K250860 — BreatheBand® (Model 1000)
- K242063 — LibAirty Airway Clearance System
- K240959 — Respiratory Muscle Trainer
- K233441 — The Vest APX System (PVAPX1)
- K222496 — Electromed SmartVest Airway Clearance System
- K201490 — Electro Flo 6 Airway Clearance System
- K203209 — AirPhysio Positive Expiratory Pressure (PEP) Device
- K173603 — Monarch Airway Clearance System
- K163378 — Monarch Airway Clearance System
- K142482 — The Vest Airway Clearance System
- K132794 — SMARTVEST AIRWAY CLEARANCE SYSTEM
- K121587 — BREATH SHAKE
- K122480 — INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST
- K121170 — RESIN 11
- K103176 — FREQUENCER
- K100749 — FREQUENCER MODEL V2X
- K063645 — FREQUENCER, MODEL 1001
- K060439 — LUNG FLUTE
- K053248 — SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL
- K051383 — THE INCOURAGE SYSTEM
- K040367 — MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ
- K031876 — ELECTRO FLO PERCUSSOR, MODEL 5000
- K024309 — THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104
- K012928 — ABI VEST AIRWAY CLEARANCE SYSTEM
- K993629 — ABI VEST AIRWAY CLEARANCE SYSTEM
- K982889 — MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000
- K974849 — X-AIR-CISER
- K972859 — FLUTTER D
- K965192 — THAIRAPY VEST SYSTEM
- K946083 — FLUTTER(R)
- K931988 — 3P (PULMONARY PERCUSSIVE PACK)
- K936121 — THAIRAPY SYSTEM
- K940986 — FLUTTER(R)
- K913014 — EMS PERCUSSOR
- K901026 — MJ PERCUSSOR(TM)
- K892862 — FLEX-CUP PERCUSSOR
- K882604 — PULMO-PATTY
- K884098 — THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101
- K883899 — MANUAL PERCUSSOR CUPS
- K880597 — THUMPER MODEL P-1000
- K863658 — SALTER LABS 3000 SERIES PERCUSSORS
- K860510 — NEONATE PERCUSSOR
- K855129 — NEOCUSSOR (MASSAGER, BATTERY) POWERED
- K853965 — NEOGUARD CHEST PERCUSSOR
- K842608 — INFANT PERCUSSOR PA-010
- K821265 — PNEUMOPULSSOR (PPS II)
- K821570 — PNEUMO PULSSOR III
- K813438 — PNEUMO PULSSOR
- K812803 — INFANT PERCUSSOR #5534
- K812151 — MJ NEONATAL PERCUSSOR
- K812166 — PERCUSSOR
- K802646 — HAND PERCUSSOR CUP #65210
- K802399 — MODEL 2500 PNEUMATIC PERCUSSOR
- K801982 — THE MCSHIRLEY PERCUSSOR
- K800713 — MJ PERCUSSOR
- K790675 — 5300 PERCUSSOR
- K771876 — ARGYLE PEOCUSSOR SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.