Atlas FDA

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

Golden Technologies, Inc. — Predicate Candidate Screening

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

43 daysmedian FDA review time
138 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K063162GOLDEN LITEWAYGolden Technologies, Inc.2006-11-02150
K041341GOLDEN SPYDER, MODEL GS-300Golden Technologies, Inc.2004-06-03140
K041025BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELEDGolden Technologies, Inc.2004-05-03121
K012258COMPANION MODEL 221, 321, 421Golden Technologies, Inc.2001-12-031380
K011153ALANTE, BATTERY OPERATED POWER WHEELCHAIRGolden Technologies, Inc.2001-05-29430
K971043GOLDEN EAGLEGolden Technologies, Inc.1997-08-011330
K971050GOLDEN HAWKGolden Technologies, Inc.1997-08-011330
K880800GOLDEN POWER LIFT CHAIRGolden Technologies, Inc.1988-03-14140

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