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

Viratek, Inc. — Predicate Candidate Screening

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

180 daysmedian FDA review time

465 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K896608	SPAG PAK	Viratek, Inc.	1990-04-09	139	0
K882396	AEROSOL DELIVERY HOOD	Viratek, Inc.	1988-08-01	52	0
K870051	SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE	Viratek, Inc.	1987-10-06	273	2
K871427	(SPAG) MODEL SPAG-2 6000 SERIES	Viratek, Inc.	1987-10-06	180	2
K843717	VIRATEK SMALL PARTICLE AEROSOL GENERAT	Viratek, Inc.	1985-12-30	465	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