Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Imagyn Medical Technologies, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
570 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032491 | ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR | Imagyn Medical Technologies, Inc. | 2003-09-04 | 23 | 0 |
| K012706 | IM2001 PULSE OXIMETER | Imagyn Medical Technologies, Inc. | 2003-03-07 | 570 | 0 |
| K010166 | IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM | Imagyn Medical Technologies, Inc. | 2001-12-03 | 319 | 0 |
| K991526 | ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 | Imagyn Medical Technologies, Inc. | 1999-06-17 | 45 | 0 |
| K980096 | OAC (OPTICAL ASPIRATING CURETTE) | Imagyn Medical Technologies, Inc. | 1998-05-01 | 112 | 0 |
| K980291 | IMPOWER EXTERNAL VACUUM SYSTEM | Imagyn Medical Technologies, Inc. | 1998-03-11 | 44 | 0 |
| K974173 | ERECAID SYSTEM/STAY EREC SYSTEM | Imagyn Medical Technologies, Inc. | 1998-02-25 | 112 | 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