Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HGH · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
266 daysmedian FDA review time
421 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172151 | Hysteroscopy System | Chongquin Jinshan Science & Technology (Group) Co., Ltd. | 2018-04-09 | 266 | 0 |
| K161106 | PANPAC DISPOSABLE VACUUM CURETTES | Panpac Medical Corporation | 2017-01-13 | 269 | 0 |
| K140213 | DISPOSABLE ENDOSCOPIC CANNULA | Dongguan Microview Medical Technology Co., Ltd. | 2015-03-25 | 421 | 0 |
| K093508 | RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (R | Womancare Global | 2010-03-04 | 112 | 0 |
| K935820 | KOLSTER METHODS | Kolster Methods | 1994-07-19 | 228 | 0 |
| K840285 | NON STRESS TEST MONITOR 507 | Imex Medical Systems, Inc. | 1984-05-09 | 106 | 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