Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DWM · Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
115 daysmedian FDA review time
346 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212696 | Aspira Pleural Drainage System | Merit Medical Systems, Inc. | 2023-03-03 | 555 | 0 |
| K210509 | Rocket Platinum Cured Cathter | Rocket Medical Plc | 2021-09-09 | 199 | 0 |
| K201404 | Passio Pump Drainage System | Bearpac Medical | 2020-11-20 | 176 | 0 |
| K190292 | Passio Pump Drainage System | Bearpac Medical | 2019-07-25 | 164 | 0 |
| K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | Rocket Medical Plc | 2017-08-17 | 265 | 0 |
| K160450 | Pleurx Pleural Catheter System | Care Fusion | 2016-10-31 | 256 | 0 |
| K141965 | PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT | Care Fusion | 2015-07-02 | 346 | 0 |
| K123033 | ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, RO | Rocket Medical Plc | 2013-02-01 | 126 | 0 |
| K121849 | PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, | Care Fusion | 2012-10-18 | 115 | 0 |
| K112831 | PLEURX PLEURAL CATHETER SYSTEMS | Care Fusion | 2012-02-16 | 141 | 0 |
| K110409 | ASPIRA PLEURAL DRAINAGE SYSTEM | C.R. Bard, Inc. | 2011-05-11 | 86 | 1 |
| K093307 | ASEPT PLEURAL DRAINAGE SYSTEM | Pfm Medical, Inc. | 2009-11-06 | 15 | 2 |
| K071095 | ASPIRA PLEURAL DRAINAGE SYSTEM | Bard Access Systems, Inc. | 2007-05-18 | 30 | 0 |
| K052436 | PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 | Denver Biomedical, Inc. | 2005-10-06 | 30 | 0 |
| K051084 | DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE W | Denver Biomedicals, Inc. | 2005-06-13 | 46 | 0 |
| K011831 | MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS | Denver Biomedical, Inc. | 2001-06-28 | 16 | 0 |
| K010642 | PLEURX PLEURAL CATHETER AND DRAINAGE KITS | Denver Biomedicals, Inc. | 2001-03-20 | 15 | 0 |
| K971753 | DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DEN | Denver Biomaterials, Inc. | 1997-06-27 | 46 | 0 |
| K803037 | WILLIAM HARVEY VENTED MEDIASTINAL DRAIN | C.R. Bard, Inc. | 1981-02-04 | 65 | 0 |
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