Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Gam Industries, Inc. — Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

127 daysmedian FDA review time
286 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K941641DISPOSABLE EMERGENCY OBSTETRICAL KITGam Industries, Inc.1994-10-031820
K941336COMBO MASKGam Industries, Inc.1994-09-091720
K942021MOUTH TO MOUTH BREATHERGam Industries, Inc.1994-06-22570
K936050JAW SPREADERGam Industries, Inc.1994-03-24940
K930401ALUMINUM FOILGam Industries, Inc.1993-05-121060
K926290BURN SHEETGam Industries, Inc.1993-04-201270
K925590MULTI-TRAUMA DRESSINGGam Industries, Inc.1993-04-081540
K915569UMBILICAL CLAMPGam Industries, Inc.1992-09-232860
K915303FOIL BABY BUNTINGGam Industries, Inc.1992-02-20910

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