Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HHM · Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
59 daysmedian FDA review time
196 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011840 | CERVILENZ UTERINE MEASURING SOUND | Cervilenz, Inc. | 2001-08-10 | 59 | 0 |
| K935665 | INTRAUTERINE SOUND | Rocket of London, Ltd. | 1994-02-24 | 90 | 0 |
| K884684 | ROCKET INTRAUTERINE DEPTH SOUND | A & A Medical, Inc. | 1988-12-20 | 42 | 0 |
| K883806 | ROCKET INTRAUTERINE SOUND | A & A Medical, Inc. | 1988-10-31 | 54 | 0 |
| K870550 | TEFLON UTERINE SOUND | Cook Ob/Gyn | 1987-03-04 | 22 | 0 |
| K840380 | UTERINE SOUND | Intl. Medical Technologies, Inc. | 1984-04-30 | 91 | 0 |
| K831224 | AUGROS HYSTEROMETER | Axcan Scientific Corp. | 1983-10-28 | 196 | 0 |
| K802315 | UTERINE SOUND | Gynemetrics, Inc. | 1981-01-12 | 111 | 0 |
| K781766 | UTERINE SOUND, BURNETT DISPOSABLE | C.R. Bard, Inc. | 1978-12-07 | 52 | 0 |
| K760170 | INTRAUTERINE SOUND, PLASTIC DISPOSABLE | G.D. Searle and Co. | 1976-07-19 | 13 | 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