Atlas FDA

KDP

21 FDA 510(k) clearances · Product code

62 daysmedian time to decision
232 days90th percentile
21clearances measured

FDA profile

Official device name
Regulator, Vacuum
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6740
Medical specialty
General Hospital
Adverse events (MAUDE)
1999: 1 · 2000: 3 · 2009: 3 · 2014: 18 · 2015: 13 · 2016: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
BOEHRINGER MRI SUCTION REGULATORY (K013976)Boehringer Laboratories2002-01-08
PM3300 INTERMITTENT VACUUM (K944479)Precision Medical, Inc.1994-12-22
MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) (K942747)Engineered Orthopedic Technologies, Inc.1994-07-21
BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED (K933232)Boehringer Laboratories1994-03-28
VACUUM POWER BODY FLUID SUCTION APPARATUS (K926140)Hill-Rom, Inc.1993-07-27
PM3000 & PM3100 VACUUM REGULATOR (K922817)Precision Medical, Inc.1993-03-04
OHMEDA CONTINUOUS SUCTION REGULATOR (K883229)Ohmeda Medical1988-10-19
VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 (K875074)Timeter Instrument Corp.1988-02-22
BOEHRINGER LAB SUCTION INTERRUPTER (K853155)Boehringer Laboratories1985-10-16
SUCTION REGULATOR 7700 SERIES (K850200)Boehringer Laboratories1985-03-04
INTERCEPT (K843591)Vital Signs, Inc.1984-10-19
VACUUM REGULATOR 0-2000 MMHG VR-1000 (K834224)Trimeter Instrument Corp.1984-02-27
THORACIC GAUGE #TG-60 -VACUUM REGULATOR (K831505)Sorensen Research1983-07-12
CONTAINER W/PRIMING SOLUTION (K830343)American Hospital Supply Corp.1983-03-17
FEVER METER (K821314)Steridyne Corp.1982-05-28
WATERLESS SEAL & VACUUM REGULATOR (K820706)Sorensen Research1982-04-09
EMERSON THORACIC SUCTION REG. #55-JP (K820077)J. H. Emerson Co.1982-01-28
OHIO FREE FLOW VACUUM REGULATOR (K801169)Ohio Medical Products1980-07-28
INSTATEMP (K770944)H.I. Silverman, D.Sc.1977-07-27
REGULATORS, LOW SUCTION (K760316)Harris-Lake, Inc.1976-08-04
REGULATORS, HIGH SUCTION (K760317)Harris-Lake, Inc.1976-08-04

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