510(k) · Cleared

Cleared

Clinical Vital Signs Monitor, Model #52STP-E1

K951193510(k) TraditionalCleared Mar 13, 1996363-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

Tycos Instruments, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Mar 13, 1996 after a 363-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 of the 422 devices in its family, counting itself, have a Class I recall. 421 later devices descend from it.

Decided: Mar 13, 1996
Review: 363 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 0

421 later devices descend from it, 6 citing it directly. 2 of the 422 devices in this family, counting this one, have a Class I recall.

This deviceK951193 Clinical Vital Signs Monitor, Model #52STP-E1Tycos Instruments, Inc. · 1996
Descendant · cites it directly · 290 of its ownK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
Descendant · cites it directly · 267 of its ownK984033 Atlas MonitorWelch Allyn, Inc. · 1999
Descendant · 2 generations on · 264 of its ownK022084 Atlas Monitor, Models 200,210,220Welch Allyn, Inc. · 2002
Descendant · 3 generations on · 250 of its ownK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
Descendant · 4 generations on · 197 of its ownK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007

Showing 5 of 421 descendants. See all descendants

Descendants cleared per year

1999high 29 (2022) · low 0 (2000)2026

Class I recalls in this family

K133576 Monitor B406 generations on · 2014
K123690 CAPNOSTREAM20P with Hifi C02 Monitoring9 generations on · 2014

Most influential descendants

Showing 5 of 421 · See all

K031740VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003 · cites it directly290descendants
K984033Atlas MonitorWelch Allyn, Inc. · 1999 · cites it directly267descendants
K022084Atlas Monitor, Models 200,210,220Welch Allyn, Inc. · 2002 · 2 generations on264descendants
K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc. · 2006 · 3 generations on250descendants
K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007 · 4 generations on197descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K951193	Clinical Vital Signs Monitor, Model #52STP-E1	Tycos Instruments, Inc.	1996	—
+1	K031740	VSM - Vital Signs Monitor, Model 53000 Series	Welch Allyn Protocol, Inc.	2003	—
+1	K984033	Atlas Monitor	Welch Allyn, Inc.	1999	—
+2	K022084	Atlas Monitor, Models 200,210,220	Welch Allyn, Inc.	2002	—
+3	K060065	CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter…	Oridion Capnography, Inc.	2006	3
+4	K072295	Capnostream 20 with A2 Adaptive Averaging Software	Oridion Capnography, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2002	3	0
2003	3	0
2004	2	0
2005	3	0
2006	6	0
2007	6	0
2008	6	0
2009	12	0
2010	19	0
2011	16	0
2012	22	0
2013	22	0
2014	24	2
2015	26	0
2016	23	0
2017	23	0
2018	25	0
2019	21	0
2020	19	0
2021	14	0
2022	29	0
2023	22	0
2024	25	0
2025	28	0
2026	21	0

FIG. 1 — Lineage of K951193, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

2 devices in this family have a Class I recall. 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

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (421)

See all 421

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

Number	Device	Applicant	Decided	Descendants
K031740	VSM - Vital Signs Monitor, Model 53000 Series	Welch Allyn Protocol, Inc.	2003	290
K984033	Atlas Monitor	Welch Allyn, Inc.	1999	267
K024005	Welch Allyn Vital Sign Monitor with MP506	Welch Allyn, Inc.	2003	102
K014255	Dinamap Procare Series Monitor; Model 100, 200, 300, 400	Ge Medical Systems Information Technologies	2002	22
K060194	March Healthcare Health Monitoring Kit	March Healthcare Corporation	2006	5
K023078	Bptru Vital Signs Monitor, Model BPM-300, & Bptru Portable Automated Non-Invasive Blood…	Vsm Medtech, Ltd.	2003	0

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 6 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 9 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K031740 (Welch Allyn Protocol, Inc., 2003) has gone furthest, with 290 descendants of its own.

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	—

https://510kreport.com/device/K951193 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951193: Clinical Vital Signs Monitor, Model #52STP-E1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951193

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026