Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KCP · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K840311 | CAT. 7-EAR, NOSE & THROAT DEVICES | Imm Enterprises , Ltd. | 1984-05-09 | 106 | 0 |
| K822754 | EAR/ULCER SYRINGE | American Hospital Supply Corp. | 1982-10-04 | 26 | 0 |
| K810284 | AUTOMATIC TEFLON INJECTION SYRINGE | R. Wolf Medical Instruments Corp. | 1981-03-11 | 37 | 0 |
| K780599 | SYRINGE, EAR & ULCER | Abco Dealers, Inc. | 1978-04-19 | 9 | 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