Atlas FDA

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

Freedom Designs, Inc. — Predicate Candidate Screening

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

41 daysmedian FDA review time
104 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K151893P.R.O. CG Manual WheelchairFreedom Designs, Inc.2015-10-221040
K080270MANUAL RIGID MOBILITY WHEELCHAIRFreedom Designs, Inc.2008-04-16750
K060926TRIPODFreedom Designs, Inc.2006-05-19451
K040622FREEDOM HPFreedom Designs, Inc.2004-04-16380
K023574GIZMOFreedom Designs, Inc.2002-12-04410
K993640SPECTRUM LIBRE WHEELCHAIRFreedom Designs, Inc.1999-11-16190
K983859SPECTRUM SMALL FRYFreedom Designs, Inc.1998-11-25300
K983763SPECTRUM SPIRITFreedom Designs, Inc.1998-11-23280
K952431SPECTRUMFreedom Designs, Inc.1995-06-22290
K944970SOLUTIONFreedom Designs, Inc.1994-12-13630

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