Atlas FDA

KRL

14 FDA 510(k) clearances · Product code

83 daysmedian time to decision
203 days90th percentile
14clearances measured

FDA profile

Official device name
Detector, Bubble, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4205
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2008: 26 · 2009: 5 · 2016: 18 · 2017: 11 · 2022: 20 · 2023: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 (K103469)Sorin Group Deutschland GmbH2011-01-18
CAPIOX BUBBLE TRAP WITH X-COATING (K090698)Terumo Cardiovascular Systems2009-06-08
EDAC QUANTIFIER (K071231)Luna Innovations, Inc.2007-05-17
AUTOMATIC TUBING CLAMP SYSTEM (ATC) (K961364)Rocky Mountain Research, Inc.1996-10-31
ELS AUTOMATIC TUBING CLAMP SYSTEM (K961598)Rocky Mountain Research, Inc.1996-10-29
SARNS ULTRASONIC AIR SENSOR (K940651)3M Health Care, Sarns1994-05-24
SARNS AIR DETECTION SYSTEM (K935977)3M Health Care, Sarns1994-02-04
STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE (K925661)Sorin Biomedica, Fiat, USA, Inc.1993-05-18
STOCKERT 1/4 BUBBLE SENSOR (K925541)Sorin Biomedica, Fiat, USA, Inc.1993-02-02
CAPIOX(R) BUBBLE TRAP (K911632)Terumo Medical Corp.1991-07-09
CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR (K864619)Shiley, Inc.1987-02-03
COBE ACCESSORY INTERFACE MODULE (AIM) (K861860)Cobe Laboratories, Inc.1986-07-18
COBE AEPS (K842054)Cobe Laboratories, Inc.1984-08-02
ARTERIAL BUBBLE TRAP K-20 (K803102)Delta Medical Industries1980-12-22

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