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

Welch Allyn, Inc. — Predicate Candidate Screening

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

72 daysmedian FDA review time

192 days90th percentile

111clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K243598	Welch Allyn Connex® 360 (Multiple)	Welch Allyn, Inc.	2025-07-13	234	0
K241411	Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor	Welch Allyn, Inc.	2024-12-20	217	1
K223381	iExaminer System with Panoptic Plus	Welch Allyn, Inc.	2023-03-15	128	0
K212473	Welch Allyn Connex Central Station	Welch Allyn, Inc.	2022-10-28	448	0
K191013	Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometr	Welch Allyn, Inc.	2019-09-10	146	1
K181016	Welch Allyn RetinaVue Network REF 901108 PACS Medical Image	Welch Allyn, Inc.	2018-07-16	90	0
K171621	Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex I	Welch Allyn, Inc.	2017-06-30	28	3
K142356	Connex Spot Monitor,901058 Vital Signs Monitor Core	Welch Allyn, Inc.	2014-12-19	116	3
K132807	MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)	Welch Allyn, Inc.	2014-01-31	144	0
K132808	VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR	Welch Allyn, Inc.	2013-11-20	70	0
K131573	CP150 ELECTROCARDIOGRAPH	Welch Allyn, Inc.	2013-07-03	34	0
K121405	PANOPTIC	Welch Allyn, Inc.	2012-12-20	224	0
K122058	FLEXIPORT ECOCUFF	Welch Allyn, Inc.	2012-11-05	115	0
K121013	CONNEX VITAL SIGNS MONITOR 6000 SERIES	Welch Allyn, Inc.	2012-07-26	114	0
K120774	ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORI	Welch Allyn, Inc.	2012-04-10	27	0
K120743	SPECULUM, VAGINAL, NONMETAL	Welch Allyn, Inc.	2012-03-23	11	1
K120343	CONNEX WORKSTATION	Welch Allyn, Inc.	2012-02-24	21	0
K112687	CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES	Welch Allyn, Inc.	2011-11-22	68	0
K110516	CONNEX VITAL SIGNS MONITOR 6000 SERIES	Welch Allyn, Inc.	2011-06-01	98	0
K101680	WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES	Welch Allyn, Inc.	2010-07-09	24	1
K101445	VITAL SIGNS MONITOR-VSM 6000 SERIES	Welch Allyn, Inc.	2010-06-08	15	0
K093907	WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE	Welch Allyn, Inc.	2010-04-14	113	0
K082478	WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62	Welch Allyn, Inc.	2009-03-09	193	0
K070060	WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PI	Welch Allyn, Inc.	2007-12-18	347	1
K072449	CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS	Welch Allyn, Inc.	2007-11-29	90	0
K071218	PROXENON 350, MODEL 902XX	Welch Allyn, Inc.	2007-06-14	43	0
K070964	KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLES	Welch Allyn, Inc.	2007-05-18	43	0
K053381	WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE	Welch Allyn, Inc.	2006-06-15	192	0
K052160	ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOU	Welch Allyn, Inc.	2005-12-16	129	2
K052784	DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 450	Welch Allyn, Inc.	2005-11-22	50	0
K053027	VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)	Welch Allyn, Inc.	2005-11-22	26	1
K052158	WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE	Welch Allyn, Inc.	2005-09-08	30	0
K050074	12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200	Welch Allyn, Inc.	2005-03-22	69	0
K040479	PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20	Welch Allyn, Inc.	2004-09-14	202	0
K040490	WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE	Welch Allyn, Inc.	2004-08-18	174	0
K033870	IMAGE MANAGEMENT SYSTEM	Welch Allyn, Inc.	2004-03-12	91	0
K031549	SOLID STATE LAMP [LED] HEADLIGHT	Welch Allyn, Inc.	2003-08-11	87	0
K031548	LED HEADLIGHT	Welch Allyn, Inc.	2003-08-11	87	0
K030580	SURETEMP PLUS	Welch Allyn, Inc.	2003-05-06	71	1
K024005	WELCH ALLYN VITAL SIGN MONITOR WITH MP506	Welch Allyn, Inc.	2003-02-12	70	0
K023495	WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)	Welch Allyn, Inc.	2002-10-31	13	0
K022084	ATLAS MONITOR, MODELS 200,210,220	Welch Allyn, Inc.	2002-09-26	91	0
K022163	WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506	Welch Allyn, Inc.	2002-09-17	76	0
K021756	WELCH ALLYN ABPM 6100	Welch Allyn, Inc.	2002-06-27	29	0
K012455	WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM	Welch Allyn, Inc.	2001-08-17	16	1
K010186	WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM	Welch Allyn, Inc.	2001-06-08	137	0
K001543	BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520	Welch Allyn, Inc.	2001-01-29	257	0
K003376	WELCH ALLYN 11800 OPTHALMOSCOPE	Welch Allyn, Inc.	2001-01-25	87	0
K002530	WELCH ALLYN SPOT CHECK DEVICE	Welch Allyn, Inc.	2000-11-14	90	0
K001265	WELCH ALLYN INSTRUMENT INTERFACE MODULE	Welch Allyn, Inc.	2000-07-13	85	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