Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medgyn Products, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
334 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K143669 | MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedG | Medgyn Products, Inc. | 2015-11-23 | 334 | 0 |
| K122973 | AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE | Medgyn Products, Inc. | 2013-06-12 | 259 | 0 |
| K945179 | BOTTLE COLLECTION SET | Medgyn Products, Inc. | 1995-01-26 | 94 | 0 |
| K880196 | LAMINARIA | Medgyn Products, Inc. | 1988-05-06 | 101 | 0 |
| K880195 | GYNESCOPE | Medgyn Products, Inc. | 1988-03-14 | 48 | 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