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

Poirier S.A. — Predicate Candidate Screening

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

38 daysmedian FDA review time

49 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days
K840638	PORTABLE TRANSIT CHAIR	Poirier S.A.	1984-03-16	56
K840639	POIRIER COMMODES	Poirier S.A.	1984-03-09	49
K840234	POIRIER VARIABLE WHEELCHAIR	Poirier S.A.	1984-02-27	38
K840627	AMPUTEE WHEELCHAIR	Poirier S.A.	1984-02-27	38
K840633	AIRPORT 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
K840629	WHEELCHAIR ACCESSORIES	Poirier S.A.	1984-02-27	38
K840630	POIRIER REGLADE WHEELCHAIR	Poirier S.A.	1984-02-27	38
K840637	HOSPITALIER WHEELCHAIR	Poirier S.A.	1984-02-27	38
K840640	POSITELEC 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
K840626	VERTICALIBRE WHEELCHAIR	Poirier S.A.	1984-02-27	38

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