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

NOU — Predicate Candidate Screening

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

401 daysmedian FDA review time

458 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K233452	Vivo 45 LS	Breas Medical AB	2025-01-13	451	1
K193586	Vivo 45 LS	Breas Medical AB	2021-01-27	401	2
K160481	Vivo 60	Breas Medical AB	2016-11-09	261	0
K123144	VIVO 50	Ge Healthcare, Breas Medical AB	2013-06-18	256	1
K034032	PLV CONTINUUM VENTILATOR, MODEL P2000	Respironics California, Inc.	2004-03-16	78	0
K022750	PLV CONTINUUM VENTILATOR, MODEL P1000	Respironics California, Inc.	2003-11-20	458	2
K021981	IVENT 201 PORTABLE VENTILATOR	Versamed , Ltd.	2003-08-13	422	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