Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Coast Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
151 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K952243 | EXTENSION SET/I.V. SET | Coast Medical, Inc. | 1995-07-26 | 75 | 0 |
| K944729 | STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED | Coast Medical, Inc. | 1994-12-21 | 86 | 5 |
| K943270 | SURFACE TEMPERATURE PROBES | Coast Medical, Inc. | 1994-12-05 | 151 | 0 |
| K943495 | DISPOSABLE ESOPHAGEAL STETHOSCOPE | Coast Medical, Inc. | 1994-09-08 | 51 | 0 |
| K943110 | GAS SAMPLING INTERFACES | Coast Medical, Inc. | 1994-08-19 | 51 | 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