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

MOD — Predicate Candidate Screening

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

272 daysmedian FDA review time

574 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260051	CorVision® (91-205-Z0014)	CorVent® Medical, Inc.	2026-05-12	124	0
K242485	EveryWare	Breas Medical AB	2025-05-20	272	0
K161411	Care Cycle Connect Application	Respironics, Inc.	2017-02-17	273	0
K091461	BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE	Cardiopulmonary Corp.	2009-08-14	88	0
K052751	VENTLINK SYSTEM	Mediserve Information Systems, Inc.	2005-12-23	84	0
K052244	IISIS, VERSION 1.0	Innovision Medical Technologies, LLC	2005-10-13	57	0
K040712	AIR SAFETY HEPA, MODEL 3500	Air Safety, Ltd.	2004-06-03	77	0
K022062	IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820	Impact Instrumentation, Inc.	2003-05-06	315	0
K010401	TRI-PLEX ADAPTER	The Medical Device Group, Inc.	2002-10-30	625	1
K011861	BERNOULLI VENTILATOR MANAGEMENT SYSTEM	Cardiopulmonary Corp.	2001-11-06	145	0
K963633	VENTNET; CENTRAL MONITORING STATION	Puritan Bennett Corp.	1996-12-16	96	0
K935788	BICORE SMARTCATH INTRATRACHEAL CATHETER	Bicore Monitoring Systems	1995-07-03	574	0
K936156	VENTILATION MECHANICS MONITOR MODEL VMM-100	Smith Industries Medical Systems (Sims)	1995-06-27	547	0
K940739	NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR	Newport Medical Instruments, Inc.	1995-03-07	383	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