Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gm Engineering, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
140 daysmedian FDA review time
362 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953348 | ARTICULATING RETRACTOR TISSUE RETRACTORS | Gm Engineering, Inc. | 1995-09-12 | 57 | 0 |
| K942626 | CONTINUOUS FLOW BIOPSY PROBE | Gm Engineering, Inc. | 1995-05-30 | 362 | 0 |
| K932394 | BERNSTEIN(TM) UTERINE MANIPULATOR | Gm Engineering, Inc. | 1995-01-26 | 618 | 0 |
| K941661 | GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT | Gm Engineering, Inc. | 1994-08-23 | 140 | 0 |
| K942703 | GM REUSABLE AND DISPOSABLE TROCAR AND GM REUSABLE AND DISPOS | Gm Engineering, Inc. | 1994-08-19 | 72 | 0 |
| K941662 | GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT | Gm Engineering, Inc. | 1994-07-20 | 106 | 0 |
| K941660 | GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT | Gm Engineering, Inc. | 1994-05-24 | 49 | 0 |
| K933962 | GM CONTINUOUS FLOW BIOPSY PROBE | Gm Engineering, Inc. | 1994-02-25 | 196 | 0 |
| K934035 | GM MONOPOLAR/FRAZIER SUCTION PROBE | Gm Engineering, Inc. | 1993-12-01 | 105 | 0 |
| K930611 | TRUE FLOW(TM) VALVE | Gm Engineering, Inc. | 1993-12-01 | 299 | 0 |
| K931398 | GM SWIVEL VIDEO (TM) IRRIGATOR | Gm Engineering, Inc. | 1993-08-30 | 164 | 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