Atlas FDA

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

Gateway Alloys, Inc. · Predicate Candidate Screening

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

22 daysmedian FDA review time
48 days90th percentile
31clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K011659GPW-SFGateway Alloys, Inc.2001-08-27900
K011661CONCORD 88Gateway Alloys, Inc.2001-08-27900
K011628CONCORD 82Gateway Alloys, Inc.2001-07-16480
K011626CONCORD 72Gateway Alloys, Inc.2001-07-16480
K964949AURORA 53Gateway Alloys, Inc.1997-01-13340
K964941EL DORADO 40Gateway Alloys, Inc.1997-01-13340
K964948AURORA 52 (PM-01)Gateway Alloys, Inc.1997-01-13340
K964950LA PLATA 28 (PM-28)Gateway Alloys, Inc.1997-01-13340
K964940TAOS 28Gateway Alloys, Inc.1997-01-13340
K964792LA PLATA 40Gateway Alloys, Inc.1996-12-20210
K964837PACIFIC 56 (CB-40)Gateway Alloys, Inc.1996-12-20210
K964789LA PLATA 39Gateway Alloys, Inc.1996-12-20210
K964838PALLADIA 85 (PM-13)Gateway Alloys, Inc.1996-12-20210
K964788EL DORADO 55Gateway Alloys, Inc.1996-12-20210
K964708SOLDER 615Gateway Alloys, Inc.1996-12-16210
K964707SOLDER 585Gateway Alloys, Inc.1996-12-16210
K964713SOLDER GPWGateway Alloys, Inc.1996-12-16210
K964706SOLDER 650Gateway Alloys, Inc.1996-12-16210
K964705SOLDER GPYGateway Alloys, Inc.1996-12-16210
K964568OZARK 46Gateway Alloys, Inc.1996-12-06220
K964567EL DORADO 75Gateway Alloys, Inc.1996-12-06220
K964572PALLADIA 76Gateway Alloys, Inc.1996-12-06220
K964573PIEDMONT 70 (CH-35)Gateway Alloys, Inc.1996-12-06220
K964566OZARK 20Gateway Alloys, Inc.1996-12-06220
K964569EL DORADO 58Gateway Alloys, Inc.1996-12-06220
K964476DE ORO 77Gateway Alloys, Inc.1996-12-04270
K964477OZARK 40Gateway Alloys, Inc.1996-12-02250
K964464PACIFIC 52 (CB-39)Gateway Alloys, Inc.1996-11-26190
K964478OSAGE 76Gateway Alloys, Inc.1996-11-26190
K964465LA PLATA 34 (PM-25)Gateway Alloys, Inc.1996-11-26190
K964466PALLADIA 75 (PM-11)Gateway Alloys, Inc.1996-11-20130

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