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

Viasys Medsystems — Predicate Candidate Screening

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

142 daysmedian FDA review time

183 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K081725	ENTERAL PUMP SET, MODEL 20-1010	Viasys Medsystems	2008-11-07	142	0
K080679	MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900	Viasys Medsystems	2008-06-27	109	0
K063061	CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900	Viasys Medsystems	2007-04-02	179	0
K043044	ANTI-I.V. ENTERAL FEEDING SYSTEM	Viasys Medsystems	2005-05-06	183	1
K050309	PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000	Viasys Medsystems	2005-03-25	45	0
K043004	STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 120	Viasys Medsystems	2005-03-16	135	0
K041987	CORTRAK	Viasys Medsystems	2004-12-17	147	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