Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HDP · 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) |
|---|---|---|---|---|---|
| K974801 | SINGLE CHANNEL BALLOON CANNULA | Conkin Surgical Instruments , Ltd. | 1998-07-09 | 199 | 0 |
| K974563 | COLPO CUP CVC-2000 | Clinical Innovations, Inc. | 1998-03-02 | 87 | 0 |
| K882054 | HYSTERO KIT | Zinnanti Surgical Instruments, Inc. | 1988-09-29 | 136 | 0 |
| K820672 | HASSON BUEC-3 | Bivona Medical Technologies | 1982-07-30 | 141 | 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