Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DWE — Predicate Candidate Screening
21 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
192 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233702 | SMARxT Tubing and Connectors | LivaNova USA, Inc. | 2024-08-08 | 265 | 0 |
| K150542 | Terumo Pump Tubing | Terumo Cardiovascular Systems Corporation | 2015-05-01 | 59 | 0 |
| K142607 | AngioVac Circuit | Angiodynamics | 2014-12-11 | 87 | 1 |
| K092486 | VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT | Vortex Medical, Inc. | 2009-08-28 | 15 | 1 |
| K080592 | HLM TUBING SET WITH BIOLINE COATING | Maquet Cardiopulmonary, AG | 2008-09-11 | 192 | 186 |
| K053025 | JOSTRA HLM TUBING SET | Maquet Cardiopulmonary, AG | 2005-11-10 | 14 | 2 |
| K022857 | PUMP TUBING WITH X-COATING | Terumo Cardiovascular Systems Corporation | 2002-09-19 | 22 | 0 |
| K013578 | PUMP TUBING | Terumo Cardiovascular Systems Corp. | 2002-01-22 | 85 | 0 |
| K993189 | CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIO | Terumo Corp. | 2000-03-01 | 160 | 0 |
| K993062 | CHEST DRAINAGE TUBING | Olson Medical Sales, Inc. | 1999-12-10 | 88 | 0 |
| K981613 | COBE SMARXT TUBING AND CONNECTORS | Cobe Cardiovascular, Inc. | 1998-10-26 | 173 | 0 |
| K923231 | CARDIO-PAK BASIC PUMP PACK | Cardio-Med-Associates, Inc. | 1993-07-09 | 373 | 1 |
| K905686 | SARNS TEMPERATURE PROBE AND CONNECTOR | 3M Health Care, Sarns | 1991-02-25 | 68 | 0 |
| K902845 | GENTLE HEADER | Enhanced Perfusion Systems, Inc. | 1990-12-03 | 158 | 0 |
| K894721 | TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE | The Traumafuse Co. | 1989-10-20 | 87 | 0 |
| K841959 | CARDIO METRIC CUSTOM PERFUSION TUBING | Sterile Design, Inc. | 1984-10-19 | 158 | 1 |
| K842044 | SARNS EVACUPLEGE CATHETER | 3M Health Care, Sarns | 1984-08-10 | 81 | 0 |
| K810924 | MEDRAD HIGH PRESSURE CONECTING TUBE | Medrad, Inc. | 1981-04-17 | 11 | 0 |
| K803277 | TYGON TUBING | Electromedics, Inc. | 1981-01-13 | 15 | 0 |
| K801394 | CARDIOPULMONARY BYPASS PUMP TUBING | Texas Medical Products, Inc. | 1980-06-30 | 17 | 0 |
| K800178 | EXTRACORP.'S INTERSEPT CUS. TUBING PK. | Extracorporeal Medical Specialities, Inc. | 1980-02-21 | 24 | 10 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda