510(k) · Cleared

Cleared

Dinamap Select Multi-Parameter System

K955113510(k) TraditionalCleared Aug 15, 1996281-day reviewClass II21 CFR 870.2340

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

Johnson & Johnson Medical, Inc. · DPS Electrocardiograph

Cleared on Aug 15, 1996 as substantially equivalent to K941811 (Hewlett-Packard Co., 1994) and 8 other predicates after a 281-day review. Its family tree reaches back 1 generation to 1989. 1 of the 54 devices in its family, counting itself, has a Class I recall. 44 later devices descend from it.

Decided: Aug 15, 1996
Review: 281 days
Class: Class II
Product code: DPS
Recalls: None
Predicates: 9

Its longest line of descent runs back 1 generation to K896030 (1989). 9 ancestors in all. 44 later devices descend from it, 3 citing it directly. 1 of the 54 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK896030 Hewlett-Packard Model M1016A CO2 & M1017A FI02Hewlett-Packard Co. · 1989
This deviceK955113 Dinamap Select Multi-Parameter SystemJohnson & Johnson Medical, Inc. · 1996
Descendant · cites it directly · 43 of its ownK971569 Dinamap MPS Portable MonitorJohnson & Johnson Medical, Inc. · 1997
Descendant · cites it directly · 40 of its ownK992638 Dinamap Pro Series Monitor, Models 100, 200, 300, 400Critikon Company, LLC · 2000
Descendant · 2 generations on · 22 of its ownK014255 Dinamap Procare Series Monitor; Model 100, 200, 300, 400Ge Medical Systems Information Technologies · 2002
Descendant · 3 generations on · 21 of its ownK022193 Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400NGe Medical Systems Information Technologies · 2002
Descendant · 4 generations on · 20 of its ownK073203 Carescape V100Ge Medical Systems Information Technologies · 2007

Showing 5 of 44 descendants. See all descendants

Descendants cleared per year

1997high 4 (2002) · low 0 (2001)2026

Class I recalls in this family

K133576 Monitor B407 generations on · 2014

Most influential descendants

Showing 5 of 44 · See all

K971569Dinamap MPS Portable MonitorJohnson & Johnson Medical, Inc. · 1997 · cites it directly43descendants
K992638Dinamap Pro Series Monitor, Models 100, 200, 300, 400Critikon Company, LLC · 2000 · cites it directly40descendants
K014255Dinamap Procare Series Monitor; Model 100, 200, 300, 400Ge Medical Systems Information Technologies · 2002 · 2 generations on22descendants
K022193Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400NGe Medical Systems Information Technologies · 2002 · 3 generations on21descendants
K073203Carescape V100Ge Medical Systems Information Technologies · 2007 · 4 generations on20descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K896030	Hewlett-Packard Model M1016A CO2 & M1017A FI02	Hewlett-Packard Co.	1989	—
0 (this device)	K955113	Dinamap Select Multi-Parameter System	Johnson & Johnson Medical, Inc.	1996	—
+1	K971569	Dinamap MPS Portable Monitor	Johnson & Johnson Medical, Inc.	1997	—
+1	K992638	Dinamap Pro Series Monitor, Models 100, 200, 300, 400	Critikon Company, LLC	2000	—
+2	K014255	Dinamap Procare Series Monitor; Model 100, 200, 300, 400	Ge Medical Systems Information Technologies	2002	—
+3	K022193	Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400N	Ge Medical Systems Information Technologies	2002	—
+4	K073203	Carescape V100	Ge Medical Systems Information Technologies	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1991	4	0
1992	1	0
1994	1	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
1999	1	0
2000	1	0
2002	4	0
2006	1	0
2007	3	0
2009	1	0
2010	3	0
2012	1	0
2013	3	0
2014	4	1
2015	3	0
2016	1	0
2017	4	0
2018	1	0
2019	2	0
2020	2	0
2021	2	0
2022	2	0
2024	2	0
2025	1	0

FIG. 1 — Lineage of K955113, 1989–2025Source: 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.

1 device in this family has 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 DPS device

#1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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? (10)

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
*	K941811	HP M1175A, M1176A, Component Monitoring System Summary page 2 …s Predicate monitoring parameters/modules and 510(k) numbers: Devices Select MPS Predicate Device & Model 510(k) Number(s) System Hewlett Packard Component Monitoring K941811 System (CMS) HP M1175A & M1176A K922058 K910490 K896030 System Hewlett Packard Omnicare™ Monitor Unknown System Marquette Medical…	Hewlett-Packard Co.	1994	—
*	K922058	Models M1175A and M1176A Component Monitoring Syst Summary page 2 …es and 510(k) numbers: Devices Select MPS Predicate Device & Model 510(k) Number(s) System Hewlett Packard Component Monitoring K941811 System (CMS) HP M1175A & M1176A K922058 K910490 K896030 System Hewlett Packard Omnicare™ Monitor Unknown System Marquette Medical Tramscope™ System K900598 ECG JIMI DINA…	Hewlett-Packard Co.	1992	—
*	K910490	Modified Monitoring System Models M1175A & M1176A Summary page 2 …10(k) numbers: Devices Select MPS Predicate Device & Model 510(k) Number(s) System Hewlett Packard Component Monitoring K941811 System (CMS) HP M1175A & M1176A K922058 K910490 K896030 System Hewlett Packard Omnicare™ Monitor Unknown System Marquette Medical Tramscope™ System K900598 ECG JIMI DINAMAP PLUS…	Hewlett-Packard Co.	1991	—
*	K896030	Hewlett-Packard Model M1016A CO2 & M1017A FI02 Summary page 2 …mbers: Devices Select MPS Predicate Device & Model 510(k) Number(s) System Hewlett Packard Component Monitoring K941811 System (CMS) HP M1175A & M1176A K922058 K910490 K896030 System Hewlett Packard Omnicare™ Monitor Unknown System Marquette Medical Tramscope™ System K900598 ECG JIMI DINAMAP PLUS Monitor…	Hewlett-Packard Co.	1989	—
*	K900598	Tramscope System Summary page 2 …nt Monitoring K941811 System (CMS) HP M1175A & M1176A K922058 K910490 K896030 System Hewlett Packard Omnicare™ Monitor Unknown System Marquette Medical Tramscope™ System K900598 ECG JIMI DINAMAP PLUS Monitor Models K943709 8710/9710 & 8720/9720 K912188 Respiration \| Hewlett Packard HP M1002A ECG/Respiratio…	Marquette Electronics, Inc.	1990	—
*	K943709	Dinamap Plus Vital Signs Monoitor Summary page 2 …& M1176A K922058 K910490 K896030 System Hewlett Packard Omnicare™ Monitor Unknown System Marquette Medical Tramscope™ System K900598 ECG JIMI DINAMAP PLUS Monitor Models K943709 8710/9710 & 8720/9720 K912188 Respiration \| Hewlett Packard HP M1002A ECG/Respiration \| K941811 Module for the Hewlett Packard CM…	Critikon Company, LLC	1995	—
*	K912188	Dinamap Plus Physiological Monitor Model 8700 Summary page 2 …30 System Hewlett Packard Omnicare™ Monitor Unknown System Marquette Medical Tramscope™ System K900598 ECG JIMI DINAMAP PLUS Monitor Models K943709 8710/9710 & 8720/9720 K912188 Respiration \| Hewlett Packard HP M1002A ECG/Respiration \| K941811 Module for the Hewlett Packard CMS Temperature \|JIMI DINAMAP PL…	Critikon Company, LLC	1991	—
*	K913695	Nellcor (R) N-180 Pulse Oximeter Summary page 3 …Summary, Continued Predicate Devices (continued) Device Description Select MPS Predicate Device & Model 510(k) Number(s) Oximetry Nellcor® Model N-180 Pulse Oximeter K913695 C0O2 Novametrix Model 1265 Endtidal CO2 Monitor \| K910019 Recorder JIMI DINAMAP PLUS Monitor Recorder K943709 Model 8726 K9121…	Nellcor, Inc.	1991	—
*	K910019	Novametrix Model 1265 End Tidal Carbon Dioxide Mon Summary page 3 …escription Select MPS Predicate Device & Model 510(k) Number(s) Oximetry Nellcor® Model N-180 Pulse Oximeter K913695 C0O2 Novametrix Model 1265 Endtidal CO2 Monitor \| K910019 Recorder JIMI DINAMAP PLUS Monitor Recorder K943709 Model 8726 K912188 The DINAMAP Select Multi Parameter System (MPS) is a pr…	Novametrix Medical Systems, Inc.	1991	3
*	—	Hewlett Packard Omnicare™ Monitor Named without a submission number			—

Also cleared against K941811: 6 other devices →

What descends from it? (44)

See all 44

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

Number	Device	Applicant	Decided	Descendants
K971569	Dinamap MPS Portable Monitor	Johnson & Johnson Medical, Inc.	1997	43
K992638	Dinamap Pro Series Monitor, Models 100, 200, 300, 400	Critikon Company, LLC	2000	40
K982641	Advanced Nibp Module	Johnson & Johnson Medical, Inc.	1999	0

Has anything in its family been recalled? (1 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 · 7 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

1 of the 9 ancestors has a recall of any class.
Of its descendants, K971569 (Johnson & Johnson Medical, Inc., 1997) has gone furthest, with 43 descendants of its own.
6 other devices also cite its predicate K941811.

How does its category compare?

All DPS devices

DPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPS

6in 2025

2007high 22 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPS

163in 2025

2007high 260 (2024) · low 31 (2008)2026

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

Recalls per year · DPS

3in 2025

2007high 9 (2019) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DPS

55in 2025

2007high 121 (2011) · low 9 (2007)2025

MAUDE reports naming product code DPS, 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	11	87	2	9
2008	13	31	0	17
2009	14	84	1	14
2010	11	104	2	21
2011	22	154	1	121
2012	12	117	0	56
2013	10	134	0	15
2014	11	253	0	15
2015	8	178	0	30
2016	11	229	0	12
2017	9	177	0	15
2018	14	221	0	19
2019	3	178	9	27
2020	6	224	2	59
2021	5	135	1	24
2022	6	244	1	59
2023	10	236	3	54
2024	8	260	4 (1)	64
2025	6	163	3	55
2026	6	258	4	—

What is it indicated for?

The DINAMAP Select MPS is intended to monitor a single patient’s vital signs at the bedside. The patient populations include adult, pediatric and neonatal. Remote monitoring is available if a network of monitors exists.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K955113 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955113: Dinamap Select Multi-Parameter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955113

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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