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

IQC · Predicate Candidate Screening

24 FDA 510(k) clearances under this product code; the 50 most recent screened below.

38 daysmedian FDA review time

68 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days
K251570	Hippocampe Marathon and Trail	Vipamat Sarl	2025-06-23	32
K120302	MECHANICAL WHEELCHAIR	Novaf Andalucia 2007, SL	2012-07-06	156
K082857	RENEGADE WHEELCHAIR	Alpha One	2009-01-06	99
K051709	HIPPOCAMPE WHEELCHAIR	Vipamat Technologie	2005-08-15	49
K895384	CALIFORNIA COMFORT FOUR WHEEL	Jubilee Scooters, Inc.	1989-09-18	19
K861943	PCI CUSTOM DESIGN SERIES	Poston & Cole Intl.	1986-05-30	10
K843213	QUALINE WHEELCHAIR PRODUCTS	Contemporary Health Sys	1984-08-24	9
K842719	STANDARD WHEELCHAIR	Greene International Corp.	1984-07-25	12
K840234	POIRIER VARIABLE WHEELCHAIR	Poirier S.A.	1984-02-27	38
K840627	AMPUTEE WHEELCHAIR	Poirier S.A.	1984-02-27	38
K840631	ARNAS WHEELCHAIR	Poirier S.A.	1984-02-27	38
K840625	UNION WHEELCHAIR	Poirier S.A.	1984-02-27	38
K840632	HEMIPLEGIC WHEELCHAIR	Poirier S.A.	1984-02-27	38
K840630	POIRIER REGLADE WHEELCHAIR	Poirier S.A.	1984-02-27	38
K840635	TRAINING WHEELCHAIR	Poirier S.A.	1984-02-27	38
K840634	OLYMPIC & BASKET WHEELCHAIRS	Poirier S.A.	1984-02-27	38
K840628	LARGE FRONT WHEELS WHEELCHAIR	Poirier S.A.	1984-02-27	38
K840636	CHILDREN'S WHEELCHAIRS	Poirier S.A.	1984-02-27	38
K834498	TRAIL CHAIR	Winchester Industries, Inc.	1984-01-30	41
K832322	BASE ONLY, TORONTO CHAIR	Intl. Medical Equipment Corp.	1983-08-12	28
K831510	FREEDOM 19 RECREATIONAL WHEELCHAIR	Carbonite Corp.	1983-07-19	68
K801317	QUADRA WHEELCHAIR, QUADRA CHAIR, ETC.	Quadra Wheelchairs, Inc.	1980-07-21	48
K770147	AVON TILTING PUSH CHAIR 14	Maddak, Inc.	1977-02-02	9
K770145	YORKHILL CHAIR	Maddak, Inc.	1977-01-28	4

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