Atlas FDA

BYT

21 FDA 510(k) clearances · Product code

81 daysmedian time to decision
147 days90th percentile
21clearances measured

FDA profile

Official device name
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5935
Medical specialty
Anesthesiology
Flags
Life-sustaining
Adverse events (MAUDE)
1993: 4 · 1994: 1 · 2001: 1 · 2004: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
RTX RESPIRATOR (K082657)Medivent Limited2008-10-08
PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS (K072290)Dima Italia Srl2008-05-29
HAYEK OSCILLATOR(TM) (K924341)Respironics, Inc.1993-07-21
NEV-10 NEGATIVE PRESSURE VENTILATOR (K910947)Lifecare Services, Inc.1991-06-03
PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM (K905530)Puritan Bennett Corp.1991-03-01
EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM (K902764)J. H. Emerson Co.1990-11-19
THE HAYEK OSCILLATOR (K903745)Flexco Medical Instruments1990-11-09
EASY BREATHER MODEL 100 ACCESSORIES (K902300)Progressive Productions , Ltd.1990-07-19
RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM (K895849)Respironics, Inc.1989-12-22
EMERSON 33-CR CHEST RESPIRATOR (K894649)Emerson Intl. Co.1989-10-13
EASY BREATHER MODEL 100 (K893213)Progressive Productions , Ltd.1989-08-04
EMERSON CHEST RESPIRATOR, MODEL 33-CRE (K881808)J. H. Emerson Co.1988-08-04
LINDLEY II RESUSCITATOR (K881689)Lindley Resuscitator, Inc.1988-07-08
Q101 DIAGNOSTIC SPIROMETER (K863300)Quinton, Inc.1986-11-13
PTR MK II VENTILATOR (K860692)Bear Medical Systems, Inc.1986-05-21
LAKEVILLE BODY VENTILATOR (K840885)Edwards Ventilator Co.1984-07-12
VENTILATOR EXTERNAL BODY NEGATIVE PRESS (K841090)Porta-Lung Co.1984-05-30
NEGATIVE PRESSURE CHEST RESPIRATOR PUMP (K832176)J. H. Emerson Co.1983-09-12
TROCKI BODY VENTRILATOR (K813326)L.T.D. 3 Co.1981-12-22
CAM-10 CUIRASS SHELL (K792673)Lifecare Services, Inc.1980-01-11
CAM-10 CHEST SHELL (K791406)Lifecare Services, Inc.1979-08-10

Track BYT automatically

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