Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Atrium Medical Corp. — Predicate Candidate Screening
63 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
183 days90th percentile
63clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130131 | EDRAIN CHEST DRAINAGE SYSTEM | Atrium Medical Corp. | 2013-02-28 | 41 | 0 |
| K122138 | ATRIUM FLIXENE IFG VASCULAR GRAFT | Atrium Medical Corp. | 2012-08-17 | 29 | 1 |
| K121070 | C-QUR RPM MESH | Atrium Medical Corp. | 2012-04-26 | 17 | 0 |
| K113112 | CLEARWAY RX NB CATHETER | Atrium Medical Corp. | 2011-11-17 | 28 | 0 |
| K102596 | ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT | Atrium Medical Corp. | 2010-10-05 | 26 | 0 |
| K093431 | CLEARWAY OTW MODEL 85912 | Atrium Medical Corp. | 2010-04-20 | 167 | 0 |
| K100076 | ATRIUM C-QUR OVT MESH | Atrium Medical Corp. | 2010-01-26 | 14 | 1 |
| K090909 | C-QUR V -PATCH MESH | Atrium Medical Corp. | 2009-06-04 | 64 | 1 |
| K082748 | ATRIUM PROLITE S MESH | Atrium Medical Corp. | 2009-01-14 | 117 | 0 |
| K081718 | EXPRESS CHEST DRAIN | Atrium Medical Corp. | 2008-07-25 | 37 | 4 |
| K080688 | C-QUR LITE MESH V-PATCH | Atrium Medical Corp. | 2008-04-16 | 36 | 0 |
| K080691 | C-QUR EDGE MESH V-PATCH | Atrium Medical Corp. | 2008-04-16 | 36 | 0 |
| K071923 | PTFE FLIXENE GRADUATED WALL GRAFT | Atrium Medical Corp. | 2007-08-14 | 33 | 18 |
| K070192 | ATRIUM PROLITE ULTRA S MESH | Atrium Medical Corp. | 2007-03-08 | 45 | 0 |
| K061680 | ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER | Atrium Medical Corp. | 2006-12-15 | 183 | 0 |
| K060396 | IVENA VASCULAR PATCH | Atrium Medical Corp. | 2006-05-12 | 86 | 0 |
| K050311 | ATRIUM MEDICAL CORPORATION C-QUR MESH | Atrium Medical Corp. | 2006-03-31 | 416 | 2 |
| K060124 | ATRIUM FLIXENE GRAFT | Atrium Medical Corp. | 2006-03-30 | 71 | 18 |
| K051332 | ADVANTA T-GRAFT | Atrium Medical Corp. | 2005-09-29 | 129 | 1 |
| K050814 | ATRIUM ICAST COVERED STENT | Atrium Medical Corp. | 2005-05-06 | 36 | 2 |
| K043582 | OCEAN CHEST DRAIN | Atrium Medical Corp. | 2005-01-21 | 24 | 17 |
| K043140 | EXPRESS AND OASIS CHEST DRAIN | Atrium Medical Corp. | 2004-12-08 | 23 | 20 |
| K041269 | ATRIUM MEDICAL CORPORATION ICAST COVERED STENT | Atrium Medical Corp. | 2004-09-14 | 125 | 0 |
| K020634 | MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BAL | Atrium Medical Corp. | 2002-05-08 | 70 | 0 |
| K020767 | ADVANTA SST BIFURCATED GRAFT | Atrium Medical Corp. | 2002-04-03 | 26 | 2 |
| K013577 | ULTRAMAX WOVEN VELOUR VASCULAR GRAFT | Atrium Medical Corp. | 2002-01-25 | 88 | 0 |
| K010517 | ADVANTA SST GRAFT (<6MM) | Atrium Medical Corp. | 2001-05-18 | 85 | 1 |
| K010516 | ADVANTA SST GRAFT (>_6MM) | Atrium Medical Corp. | 2001-05-18 | 85 | 2 |
| K002627 | ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER | Atrium Medical Corp. | 2001-04-26 | 246 | 0 |
| K002093 | ATRIUM LITE MESH | Atrium Medical Corp. | 2000-07-24 | 13 | 0 |
| K000499 | ADVANTA SUPER SOFT GRAFT | Atrium Medical Corp. | 2000-03-01 | 15 | 1 |
| K000504 | ADVANTA SUPER SOFT GRAFT | Atrium Medical Corp. | 2000-03-01 | 15 | 1 |
| K992991 | ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT | Atrium Medical Corp. | 2000-01-27 | 142 | 0 |
| K992776 | UNI-GRAFT K DV PATCH | Atrium Medical Corp. | 1999-11-16 | 90 | 0 |
| K992960 | ADVANTA GRAFT (>6MM) | Atrium Medical Corp. | 1999-10-01 | 29 | 38 |
| K992958 | ADVANTA GRAFT (<6MM) | Atrium Medical Corp. | 1999-10-01 | 29 | 15 |
| K992443 | ADVANTA GRAFT | Atrium Medical Corp. | 1999-08-20 | 29 | 1 |
| K992441 | ADVANTA GRAFT | Atrium Medical Corp. | 1999-08-20 | 29 | 1 |
| K991813 | UNI-GRAFT K DV VASCULAR GRAFT | Atrium Medical Corp. | 1999-06-01 | 5 | 0 |
| K984496 | ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN | Atrium Medical Corp. | 1999-05-05 | 139 | 0 |
| K963790 | UNI-GRAFT K DV | Atrium Medical Corp. | 1997-07-21 | 304 | 0 |
| K950677 | ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN | Atrium Medical Corp. | 1995-04-13 | 58 | 0 |
| K933391 | ATRIUM'S HYBRID PTFE | Atrium Medical Corp. | 1994-12-15 | 521 | 0 |
| K930669 | ATRIUM POLYPROPYLENE MESH | Atrium Medical Corp. | 1993-12-16 | 308 | 0 |
| K925123 | ATRIUM'S HYBRID PTFE | Atrium Medical Corp. | 1993-05-27 | 226 | 0 |
| K912956 | ATRIUM DUAL ATS WATER SEAL CHEST DRAIN UNIT | Atrium Medical Corp. | 1991-11-29 | 144 | 0 |
| K912610 | MINI-OP ATS BLOOD RECOVERY BAG, MODEL 2955 | Atrium Medical Corp. | 1991-11-29 | 170 | 0 |
| K912609 | MINI-OP ATS BLOOD RECOVERY BAG, MOEL 2950 | Atrium Medical Corp. | 1991-11-29 | 170 | 0 |
| K912645 | ATRIUMS PDR THORACIC CATHETER | Atrium Medical Corp. | 1991-09-13 | 88 | 17 |
| K912704 | ATRIUM 2000 CHEST DRAIN | Atrium Medical Corp. | 1991-08-26 | 68 | 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