Atlas FDA

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

Amigo Sales, Inc. — Predicate Candidate Screening

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

29 daysmedian FDA review time
112 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K871391AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED)Amigo Sales, Inc.1987-05-06290
K853918THE SPORTSTER (ELECTRIFIED WHEELCHAIR)Amigo Sales, Inc.1986-01-131120
K852557ALL TERRAIN AMIGOAmigo Sales, Inc.1985-08-22660
K830345SCOOTER, VEHICLE MOTORIZEDAmigo Sales, Inc.1983-03-10410
K823117HITCH HIKERAmigo Sales, Inc.1982-11-16260
K820858ESCORTAmigo Sales, Inc.1982-04-08100
K800209BOOTS - OUTDOOR CARRIER FOR THE AMIGOAmigo Sales, Inc.1980-02-22210

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