Coeur Laboratories, Inc.: FDA clearances and approvals
Coeur Laboratories, Inc. has 10 FDA 510(k) clearances (first 1983, latest 1997), across 5 product codes in 4 review panels. Median 510(k) review time: 72 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | 5 | 5 |
| KOD | Catheter, Urological | 2 | 2 |
| DTX | Gas Control Unit, Cardiopulmonary Bypass | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| GIO | Tube, Collection, Capillary Blood | 1 | 1 |
Review panels
Most recent Coeur Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971712 | COEUR 130 ML ANGIOGRAPHIC SYRINGE | DXT | 1997-10-08 | 152 |
| K965214 | COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) | DTX | 1997-03-28 | 88 |
| K960965 | FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 | DXT | 1996-09-12 | 185 |
| K890292 | PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE | DXT | 1989-06-22 | 154 |
| K885138 | CAPILLARY TUBE, BLOOD COLLECTION | GIO | 1989-02-07 | 54 |
| K885202 | 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR | KOD | 1989-01-31 | 46 |
| K881646 | UROLOGICAL CATHETER | KOD | 1988-06-16 | 62 |
| K874579 | COEUR CONTROL SYRINGE | FMF | 1988-01-19 | 74 |
| K873597 | TUBING, POLYETHYLENE | DXT | 1987-11-12 | 69 |
| K823920 | COEURLOCK STERILE DISPOS. ANGIOGRAPHIC | DXT | 1983-02-18 | 52 |
Recalls
openFDA lists no recalls under a recalling firm named Coeur Laboratories, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances does Coeur Laboratories, Inc. have?
Coeur Laboratories, Inc. has 10 FDA 510(k) clearances (first 1983, latest 1997), across 5 product codes in 4 review panels.
How long does FDA take to clear Coeur Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Coeur Laboratories, Inc.'s cleared 510(k)s is 72 days.
What devices does Coeur Laboratories, Inc. make?
Its most frequent FDA product codes are DXT (Injector And Syringe, Angiographic, 5); KOD (Catheter, Urological, 2); DTX (Gas Control Unit, Cardiopulmonary Bypass, 1).
Has Coeur Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Coeur Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 10 Coeur Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXT, Coeur Laboratories, Inc.'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.