Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sharn, Inc. — 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) |
|---|---|---|---|---|---|
| K070596 | TOPICAL APPLICATOR | Sharn, Inc. | 2007-06-21 | 111 | 3 |
| K932305 | VILA-COOKE(TM) ANESTHESIA PILLOW | Sharn, Inc. | 1993-10-05 | 146 | 0 |
| K894032 | EVAC-TUBE | Sharn, Inc. | 1989-08-31 | 86 | 0 |
| K860558 | ESOPHAGEAL STETHOSCOPE | Sharn, Inc. | 1986-04-01 | 46 | 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