Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HHF — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
91 daysmedian FDA review time
421 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K926541 | IUD HOOKS | Thomasville Medical Assoc. | 1994-02-24 | 421 | 0 |
| K891030 | IUD HOOKS - SIMPLE, UNIVERSAL AND SKLAR | Zinnanti Surgical Instruments, Inc. | 1989-03-17 | 17 | 0 |
| K842295 | INTRAUTERINE DEVICE REMOVER | Premier Dental Products Co. | 1984-10-12 | 123 | 0 |
| K831568 | RELIANCE TEMPO OPHTH. INSTR STAND | F. & F. Koenigkramer | 1983-06-30 | 45 | 0 |
| K820115 | EMMETT IUD THREAD RETREIVER | Proto-Med, Inc. | 1982-02-05 | 18 | 0 |
| K811761 | THE EMMETT IUD THREAD RETRIEVER | Proto-Med, Inc. | 1981-09-21 | 91 | 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