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

Stackhouse Assoc. — Predicate Candidate Screening

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

86 daysmedian FDA review time

105 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K912651	AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM	Stackhouse Assoc.	1991-07-08	21	0
K910515	FREEDOM MARK III SURGICAL HELMET SYSTEM	Stackhouse Assoc.	1991-05-06	90	15
K874512	MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM	Stackhouse Assoc.	1988-01-27	86	0
K872935	ANTI-INFECTION SHIELD	Stackhouse Assoc.	1987-11-09	105	0
K790877	BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO	Stackhouse Assoc.	1979-05-23	16	0

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