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

Richard-Allan Medical — Predicate Candidate Screening

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

123 daysmedian FDA review time

298 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K942207	REFLEX INS INSUFFLATION NEEDLE	Richard-Allan Medical	1994-05-27	22
K935105	REFLEX ESP WITH FINGER SWITCHES	Richard-Allan Medical	1994-02-22	123
K933508	REFLEX SDD SURGICAL STAPLER	Richard-Allan Medical	1993-11-23	126
K933901	REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER)	Richard-Allan Medical	1993-11-19	101
K924881	REFLEX(R) ESP	Richard-Allan Medical	1993-07-23	298
K924929	REFLEX(R) ECA	Richard-Allan Medical	1993-07-21	294
K905701	RICHARD-ALLAN SHEET CLIP	Richard-Allan Medical	1991-02-19	61
K905682	RICHARD-ALLAN CLAMP COVERS	Richard-Allan Medical	1991-02-19	62

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