510(k) · Cleared

Cleared

Welch Allyn Vital Sign Monitor with MP506

K024005510(k) SpecialCleared Feb 12, 200370-day reviewClass II21 CFR 870.1130

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Welch Allyn, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Feb 12, 2003 as substantially equivalent to K951193 (Tycos Instruments, Inc., 1996) after a 70-day review. Its family tree reaches back 1 generation to 1996. 102 later devices descend from it.

Decided: Feb 12, 2003
Review: 70 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K951193 (1996). 102 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK951193 Clinical Vital Signs Monitor, Model #52STP-E1Tycos Instruments, Inc. · 1996
This deviceK024005 Welch Allyn Vital Sign Monitor with MP506Welch Allyn, Inc. · 2003
Descendant · cites it directly · 97 of its ownK040490 Welch Allyn Spot Ultra Vital Signs DeviceWelch Allyn, Inc. · 2004
Descendant · 2 generations on · 74 of its ownK093907 Welch Allyn Non Invasive Blood Pressure (Nibp) DeviceWelch Allyn, Inc. · 2010
Descendant · 2 generations on · 73 of its ownK101445 Vital Signs Monitor-VSM 6000 SeriesWelch Allyn, Inc. · 2010
Descendant · 3 generations on · 67 of its ownK110516 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
Descendant · 4 generations on · 66 of its ownK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011

Showing 5 of 102 descendants. See all descendants

Descendants cleared per year

2004high 12 (2024) · low 0 (2006)2026

Most influential descendants

Showing 5 of 102 · See all

K040490Welch Allyn Spot Ultra Vital Signs DeviceWelch Allyn, Inc. · 2004 · cites it directly97descendants
K093907Welch Allyn Non Invasive Blood Pressure (Nibp) DeviceWelch Allyn, Inc. · 2010 · 2 generations on74descendants
K101445Vital Signs Monitor-VSM 6000 SeriesWelch Allyn, Inc. · 2010 · 2 generations on73descendants
K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011 · 3 generations on67descendants
K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011 · 4 generations on66descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951193	Clinical Vital Signs Monitor, Model #52STP-E1	Tycos Instruments, Inc.	1996	—
0 (this device)	K024005	Welch Allyn Vital Sign Monitor with MP506	Welch Allyn, Inc.	2003	—
+1	K040490	Welch Allyn Spot Ultra Vital Signs Device	Welch Allyn, Inc.	2004	—
+2	K093907	Welch Allyn Non Invasive Blood Pressure (Nibp) Device	Welch Allyn, Inc.	2010	—
+2	K101445	Vital Signs Monitor-VSM 6000 Series	Welch Allyn, Inc.	2010	—
+3	K110516	Connex Vital Signs Monitor 6000 Series	Welch Allyn, Inc.	2011	—
+4	K112687	Connex (R) Vital Signs Monitor 6000 Series	Welch Allyn, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2008	1	0
2010	5	0
2011	2	0
2012	5	0
2013	1	0
2014	8	0
2015	1	0
2016	8	0
2017	5	0
2018	3	0
2019	7	0
2020	7	0
2021	3	0
2022	11	0
2023	6	0
2024	12	0
2025	9	0
2026	6	0

FIG. 1 — Lineage of K024005, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DXN device

#1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K951193	Clinical Vital Signs Monitor, Model #52STP-E1 Summary page 1 …0.1 130 Noninvasive Blood Pressure Measurement System). E. Predicate Device Welch Allyn Vital Signs Monitor Welch Allyn, Inc. 51 Ow) Document Control Number K95 1193 F. Description of the Device The Welch Allyn Vital Signs Monitor is designed to non-invasively and automaticallymeasure…	Tycos Instruments, Inc.	1996	—
†	K012891	Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…	Nellcor Puritan Bennett, Inc.	2002	1
†	K002530	Welch Allyn Spot Check Device	Welch Allyn, Inc.	2000	—

Also cleared against K951193: 5 other devices →

What descends from it? (102)

See all 102

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K040490	Welch Allyn Spot Ultra Vital Signs Device	Welch Allyn, Inc.	2004	97
K051375	Vital Signs Monitor	Mediana Co., Ltd.	2005	3

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K040490 (Welch Allyn, Inc., 2004) has gone furthest, with 97 descendants of its own.
5 other devices also cite its predicate K951193.

How does its category compare?

All DXN devices

DXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXN

28in 2025

2007high 46 (2009) · low 17 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXN

142in 2025

2007high 235 (2018) · low 72 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXN

3in 2024

2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXN

239in 2025

2007high 617 (2018) · low 8 (2008)2025

MAUDE reports naming product code DXN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	27	118	0	21
2008	23	82	1	8
2009	46	73	3	17
2010	43	94	0	14
2011	34	72	1	10
2012	36	116	0	19
2013	34	150	1	72
2014	29	133	0	47
2015	30	97	0	62
2016	30	144	1	54
2017	33	184	0	90
2018	22	235	0	617
2019	33	156	1	96
2020	24	198	0	130
2021	23	190	0	162
2022	25	137	0	155
2023	35	182	0	162
2024	17	107	3	270
2025	28	142	0	239
2026	29	147	0	—

What is it indicated for?

The Welch Allyn Vital Signs Monitor is intended for monitoring of blood pressure, pulse rate, temperature and oxygen saturation (SpO2) of adult and pediatric patients. The device is not designed, sold or intended for use except as indicated.

* The Welch Allyn Vital Signs Monitor is not designed for use with neonates. To ensure pediatric blood pressure accuracy and safety, note that the Welch Allyn Small Child cuffs are the smallest cuffs approved for use with young children and infants. The circumference of the child’s arm must fit within the range markings on the cuff.

* The Welch Allyn Vital Signs Monitor should not be used on patients who are linked to heart/lung machines.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024005 · printed Nov 3, 2026

Cite this page

510(k) Report. “K024005: Welch Allyn Vital Sign Monitor with MP506.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024005

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026