Atlas FDA

BXP

7 FDA 510(k) clearances · Product code

73 daysmedian time to decision
211 days90th percentile
7clearances measured

FDA profile

Official device name
Transducer, Gas Flow
Device class
Class I (low risk)
Regulation
21 CFR 868.2885
Medical specialty
Anesthesiology
Adverse events (MAUDE)
1999: 1 · 2001: 1 · 2005: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
UNIPOWER RECHARGEABLE BATTERY PACK (K936141)Unipower Corp.1994-03-31
TIMOX OXYGEN TIMER (K920360)Medical Fittings, Inc.1992-08-03
PHONATORY FUNCTION ANALYZER PS-77 (K832678)Kells Medical, Inc.1984-03-07
ULTRASONIC FLOWMETER (K800087)The Perkin-Elmer Corp.1980-03-19
OXY-ON DIGITAL OXYGEN TIMER (K781039)Chambers & Sadler Mfg.1978-08-31
OXYGEN TWMER, MODEL SST (K770424)Timeter Instrument Corp.1977-03-16
ARIZONA OXYGEN TIMER DEVICE (K761260)The John Bunn Co.1976-12-16

Track BXP automatically

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