Atlas FDA

BYH

22 FDA 510(k) clearances · Product code

39 daysmedian time to decision
110 days90th percentile
22clearances measured

FDA profile

Official device name
Drain, Tee (Water Trap)
Device class
Class I (low risk)
Regulation
21 CFR 868.5995
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2003: 1 · 2004: 1 · 2005: 1 · 2006: 4 · 2007: 2 · 2016: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
AQUALARM MOISTURE SENSOR MODEL P85000 (K946057)Pegasus Research Corp.1995-05-05
CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEM (K932722)Carie Med-Tech Services, Inc.1993-08-06
DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS (K921624)Intertech Resources, Inc.1992-06-30
THAYER SUCTION EVACUATION CONDENSATE COLLECTION (K900047)Thayer Medical Corp.1990-04-23
THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM (K897057)Thayer Medical Corp.1990-03-16
THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM (K895479)Thayer Medical Corp.1990-03-09
VENT-TRAP CAT# WR1000 (K900591)Ventlab Corp.1990-03-09
THAYER FLEXIBLE CONDENSATE COLLECTION SYSTEM (K885088)Thayer Medical Corp.1989-01-12
INTERTECH LARGE VOLUME WATER TRAP (LVW) (K882739)Intertech Resources, Inc.1988-08-09
SAFETY DRAIN (K881790)Ballard Medical Products1988-06-21
DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR (K873447)Dhd Medical Products Div. Diemolding Corp.1987-10-30
AQUAVALVE (K864147)Respiratory Care, Inc.1986-12-05
SELF-SEALING WATER TRAP/ACCESSORIES (K860884)Dhd Medical Products Div. Diemolding Corp.1986-03-19
SELF-SEALING WATER TRAP/ADULT/PAEDIATRIC CIRCUITS (K860883)Dhd Medical Products Div. Diemolding Corp.1986-03-19
SPLASH ADAPTOR (K853665)Ohio Medical Research, Inc.1985-10-10
AQUA TRAP (K834573)Airlife, Inc.1984-03-05
MOISTURE TRAP (K820936)Dhd Medical Products Div. Diemolding Corp.1982-04-29
SHERWOOD WATER TRAP (K812569)Sherwood Medical Co.1981-09-25
TRACH MIST UNIT W/OR WITHOUT ELBOW (K800990)Airlife, Inc.1980-05-08
MOISTURE TRAP (K792390)Dhd Medical Products Div. Diemolding Corp.1979-12-04
DRAINAGE BAG (K790929)Mem Medical, Inc.1979-05-21
AEROSOL EFFUSION SYSTEM #1740 (K770771)Hudson Oxygen Therapy Sales Co.1977-06-02

Track BYH automatically

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