Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gics Pharmaceuticals — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K802890 | CPS-1000 | Gics Pharmaceuticals | 1981-03-05 | 108 | 0 |
| K801138 | MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN. | Gics Pharmaceuticals | 1980-07-14 | 63 | 0 |
| K801136 | D300 DOME | Gics Pharmaceuticals | 1980-06-20 | 39 | 0 |
| K800849 | TMS 1000 TEMP. MONITOR & PROBES | Gics Pharmaceuticals | 1980-05-08 | 23 | 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