Atrium Medical Corp.: FDA clearances and approvals
Atrium Medical Corp. has 69 FDA 510(k) clearances (first 1981, latest 2024), plus 1 PMA decision, across 15 product codes in 4 review panels. Median 510(k) review time: 68 days. openFDA lists 180 product recalls by a recalling firm named Atrium Medical Corp. It is the industry lead sponsor of 5 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 23 |
| 2013 | 2 | 46 |
| 2014 | 0 | — |
| 2015 | 2 | 120 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 476 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 269 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Atrium Medical Corp.'s cleared 510(k)s took a median 372 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 18 | 18 |
| FTL | Mesh, Surgical, Polymeric | 14 | 14 |
| CAC | Apparatus, Autotransfusion | 10 | 10 |
| KDQ | Bottle, Collection, Vacuum | 8 | 8 |
| DYF | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | 4 | 4 |
| DQY | Catheter, Percutaneous | 3 | 3 |
| DXE | Catheter, Embolectomy | 3 | 3 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 | 2 |
| JCT | Prosthesis, Tracheal, Expandable | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
Plus 5 more product codes.
Review panels
- Cardiovascular (43)
- General and Plastic Surgery (17)
- General Hospital (8)
- Anesthesiology (2)
Most recent Atrium Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231972 | Advanta VXT Vascular Graft, Flixene Vascular Graft | DSY | 2024-03-28 | 269 |
| K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain | CAC | 2021-09-03 | 476 |
| K151386 | C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic | FTL | 2015-10-22 | 149 |
| K151437 | ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug | FTL | 2015-08-27 | 90 |
| K130142 | FLIXENE IFG VASCULAR GRAFT | DSY | 2013-03-15 | 52 |
| K130131 | EDRAIN CHEST DRAINAGE SYSTEM | BTA | 2013-02-28 | 41 |
| K122138 | ATRIUM FLIXENE IFG VASCULAR GRAFT | DSY | 2012-08-17 | 29 |
| K121070 | C-QUR RPM MESH | FTL | 2012-04-26 | 17 |
| K113112 | CLEARWAY RX NB CATHETER | DQY | 2011-11-17 | 28 |
| K110110 | ATRIUM CENTRILFX MESH | FTL | 2011-02-15 | 32 |
59 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P120003 | PMA | iCast Covered Stent System | 2023-03-22 |
Recalls
180 product recalls in 32 recall events; 87 initiated in the last five years. Most recent: 2026-08-07.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Atrium Medical Corp. is the industry lead sponsor of 5 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07161583: Advanta VXT and Flixene PMCF Registry (Recruiting, started 2025-09-25)
- NCT01673373: Renal Stent Placement for the Treatment of Renal Artery Stenosis in Patients With Resistant Hypertension (Completed, started 2012-10-23)
- NCT00978952: Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta (Completed, started 2009-09)
- NCT00804024: ClearWay™ RX Registry Trial (Completed, started 2008-08)
- NCT00593385: Atrium iCAST Iliac Stent Pivotal Study (Completed, started 2007-10)
Frequently asked questions
How many FDA 510(k) clearances does Atrium Medical Corp. have?
Atrium Medical Corp. has 69 FDA 510(k) clearances (first 1981, latest 2024), plus 1 PMA decision, across 15 product codes in 4 review panels.
How long does FDA take to clear Atrium Medical Corp.'s 510(k)s?
The median time from FDA receipt to decision across Atrium Medical Corp.'s cleared 510(k)s is 68 days.
What devices does Atrium Medical Corp. make?
Its most frequent FDA product codes are DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, 18); FTL (Mesh, Surgical, Polymeric, 14); CAC (Apparatus, Autotransfusion, 10).
Has Atrium Medical Corp. had device recalls?
openFDA lists 180 product recalls in 32 recall events by a recalling firm whose name matches Atrium Medical Corp; the most recent began 2026-08-07. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 69 Atrium Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code DSY, Atrium Medical Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.