Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Chesire Laboratories — 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) |
|---|---|---|---|---|---|
| K924265 | DOCTOR'S CHOICE LATEX EXAMINATION GLOVES | Chesire Laboratories | 1993-03-15 | 203 | 0 |
| K924266 | DOCTOR'S CHOICE POWDER FREE LATEX EXAM GLOVES | Chesire Laboratories | 1993-02-10 | 170 | 0 |
| K770233 | STERILE SUCTION CATHETER W/CONTROL | Chesire Laboratories | 1977-04-05 | 57 | 0 |
| K770231 | MID-STREAM COLLECTION SET | Chesire Laboratories | 1977-03-30 | 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