Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Coeur Laboratories, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
185 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971712 | COEUR 130 ML ANGIOGRAPHIC SYRINGE | Coeur Laboratories, Inc. | 1997-10-08 | 152 | 0 |
| K965214 | COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) | Coeur Laboratories, Inc. | 1997-03-28 | 88 | 0 |
| K960965 | FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD | Coeur Laboratories, Inc. | 1996-09-12 | 185 | 0 |
| K890292 | PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE | Coeur Laboratories, Inc. | 1989-06-22 | 154 | 0 |
| K885138 | CAPILLARY TUBE, BLOOD COLLECTION | Coeur Laboratories, Inc. | 1989-02-07 | 54 | 0 |
| K885202 | 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR | Coeur Laboratories, Inc. | 1989-01-31 | 46 | 0 |
| K881646 | UROLOGICAL CATHETER | Coeur Laboratories, Inc. | 1988-06-16 | 62 | 0 |
| K874579 | COEUR CONTROL SYRINGE | Coeur Laboratories, Inc. | 1988-01-19 | 74 | 0 |
| K873597 | TUBING, POLYETHYLENE | Coeur Laboratories, Inc. | 1987-11-12 | 69 | 0 |
| K823920 | COEURLOCK STERILE DISPOS. ANGIOGRAPHIC | Coeur Laboratories, Inc. | 1983-02-18 | 52 | 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