Atlas FDA

DWE

21 FDA 510(k) clearances · Product code

85 daysmedian time to decision
192 days90th percentile
21clearances measured

FDA profile

Official device name
Tubing, Pump, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4390
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 41 · 2022: 123 · 2023: 286 · 2024: 221 · 2025: 82 · 2026: 24
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SMARxT Tubing and Connectors (K233702)LivaNova USA, Inc.2024-08-08
Terumo Pump Tubing (K150542)Terumo Cardiovascular Systems Corporation2015-05-01
AngioVac Circuit (K142607)Angiodynamics2014-12-11
VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT (K092486)Vortex Medical, Inc.2009-08-28
HLM TUBING SET WITH BIOLINE COATING (K080592)Maquet Cardiopulmonary, AG2008-09-11
JOSTRA HLM TUBING SET (K053025)Maquet Cardiopulmonary, AG2005-11-10
PUMP TUBING WITH X-COATING (K022857)Terumo Cardiovascular Systems Corporation2002-09-19
PUMP TUBING (K013578)Terumo Cardiovascular Systems Corp.2002-01-22
CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING (K993189)Terumo Corp.2000-03-01
CHEST DRAINAGE TUBING (K993062)Olson Medical Sales, Inc.1999-12-10
COBE SMARXT TUBING AND CONNECTORS (K981613)Cobe Cardiovascular, Inc.1998-10-26
CARDIO-PAK BASIC PUMP PACK (K923231)Cardio-Med-Associates, Inc.1993-07-09
SARNS TEMPERATURE PROBE AND CONNECTOR (K905686)3M Health Care, Sarns1991-02-25
GENTLE HEADER (K902845)Enhanced Perfusion Systems, Inc.1990-12-03
TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE (K894721)The Traumafuse Co.1989-10-20
CARDIO METRIC CUSTOM PERFUSION TUBING (K841959)Sterile Design, Inc.1984-10-19
SARNS EVACUPLEGE CATHETER (K842044)3M Health Care, Sarns1984-08-10
MEDRAD HIGH PRESSURE CONECTING TUBE (K810924)Medrad, Inc.1981-04-17
TYGON TUBING (K803277)Electromedics, Inc.1981-01-13
CARDIOPULMONARY BYPASS PUMP TUBING (K801394)Texas Medical Products, Inc.1980-06-30
EXTRACORP.'S INTERSEPT CUS. TUBING PK. (K800178)Extracorporeal Medical Specialities, Inc.1980-02-21

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