510(k) Report

510(k) · Cleared

Cleared

Dinamap Plus Vital Signs Monoitor

K943709510(k) TraditionalCleared Jun 16, 1995319-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

Critikon Company, LLC · DPS Electrocardiograph

Cleared on Jun 16, 1995 after a 319-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 47 devices in its family, counting itself, has a Class I recall. 46 later devices descend from it.

Decided
Jun 16, 1995
Review
319 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
0

46 later devices descend from it, 2 citing it directly. 1 of the 47 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1997: 2 descendants cleared1996: 1 descendant cleared2000: 1 descendant cleared1999: 1 descendant cleared1998: 1 descendant cleared2002: 4 descendants cleared2007: 3 descendants cleared2006: 1 descendant cleared2010: 3 descendants cleared2009: 1 descendant cleared2014: 4 descendants cleared, 1 with a Class I recall12013: 3 descendants cleared2021: 2 descendants cleared2012: 1 descendant cleared2022: 2 descendants cleared2017: 4 descendants cleared2016: 1 descendant cleared2015: 3 descendants cleared2019: 2 descendants cleared2024: 2 descendants cleared2020: 2 descendants cleared2018: 1 descendant cleared2025: 1 descendant cleared1995200020052010201520202025
  1. This deviceK943709 Dinamap Plus Vital Signs MonoitorCritikon Company, LLC · 1995
  2. Descendant · cites it directly · 44 of its ownK955113 Dinamap Select Multi-Parameter SystemJohnson & Johnson Medical, Inc. · 1996
  3. Descendant · 2 generations on · 43 of its ownK971569 Dinamap MPS Portable MonitorJohnson & Johnson Medical, Inc. · 1997
  4. Descendant · cites it directly · 41 of its ownK970182 Dinamap Compact MonitorJohnson & Johnson Medical, Inc. · 1997
  5. Descendant · 2 generations on · 40 of its ownK992638 Dinamap Pro Series Monitor, Models 100, 200, 300, 400Critikon Company, LLC · 2000
  6. Descendant · 3 generations on · 22 of its ownK014255 Dinamap Procare Series Monitor; Model 100, 200, 300, 400Ge Medical Systems Information Technologies · 2002

Showing 5 of 46 descendants. See all descendants

Descendants cleared per year

1996: 11997: 21998: 11999: 12000: 12002: 42006: 12007: 32009: 12010: 32012: 12013: 32014: 42015: 32016: 12017: 42018: 12019: 22020: 22021: 22022: 22024: 22025: 1
1996high 4 (2002) · low 0 (2001)2026

Class I recalls in this family

  • K133576 Monitor B408 generations on · 2014

Most influential descendants

Showing 5 of 46 · See all
  • K955113Dinamap Select Multi-Parameter SystemJohnson & Johnson Medical, Inc. · 1996 · cites it directly44descendants
  • K971569Dinamap MPS Portable MonitorJohnson & Johnson Medical, Inc. · 1997 · 2 generations on43descendants
  • K970182Dinamap Compact MonitorJohnson & Johnson Medical, Inc. · 1997 · cites it directly41descendants
  • K992638Dinamap Pro Series Monitor, Models 100, 200, 300, 400Critikon Company, LLC · 2000 · 2 generations on40descendants
  • K014255Dinamap Procare Series Monitor; Model 100, 200, 300, 400Ge Medical Systems Information Technologies · 2002 · 3 generations on22descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943709Dinamap Plus Vital Signs MonoitorCritikon Company, LLC1995—
+1K955113Dinamap Select Multi-Parameter SystemJohnson & Johnson Medical, Inc.1996—
+2K971569Dinamap MPS Portable MonitorJohnson & Johnson Medical, Inc.1997—
+1K970182Dinamap Compact MonitorJohnson & Johnson Medical, Inc.1997—
+2K992638Dinamap Pro Series Monitor, Models 100, 200, 300, 400Critikon Company, LLC2000—
+3K014255Dinamap Procare Series Monitor; Model 100, 200, 300, 400Ge Medical Systems Information Technologies2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199720
199810
199910
200010
200240
200610
200730
200910
201030
201210
201330
201441
201530
201610
201740
201810
201920
202020
202120
202220
202420
202510
FIG. 1 — Lineage of K943709, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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. #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (46)

See all 46

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

NumberDeviceApplicantDecidedDescendants
K955113Dinamap Select Multi-Parameter SystemJohnson & Johnson Medical, Inc.199644
K970182Dinamap Compact MonitorJohnson & Johnson Medical, Inc.199741

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 · 8 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K955113 (Johnson & Johnson Medical, Inc., 1996) has gone furthest, with 44 descendants of its own.

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

2007: 112008: 132009: 142010: 112011: 222012: 122013: 102014: 112015: 82016: 112017: 92018: 142019: 32020: 62021: 52022: 62023: 102024: 82025: 62026 (partial year): 6
2007high 22 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPS

163in 2025

2007: 87 days median2008: 31 days median2009: 84 days median2010: 104 days median2011: 154 days median2012: 117 days median2013: 134 days median2014: 253 days median2015: 178 days median2016: 229 days median2017: 177 days median2018: 221 days median2019: 178 days median2020: 224 days median2021: 135 days median2022: 244 days median2023: 236 days median2024: 260 days median2025: 163 days median2026 (partial year): 258 days median
2007high 260 (2024) · low 31 (2008)2026

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

Recalls per year · DPS

3in 2025

2007: 22009: 12010: 22011: 12019: 92020: 22021: 12022: 12023: 32024: 4, 1 Class I2025: 32026 (partial year): 4
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

2007: 92008: 172009: 142010: 212011: 1212012: 562013: 152014: 152015: 302016: 122017: 152018: 192019: 272020: 592021: 242022: 592023: 542024: 642025: 55
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007118729
20081331017
20091484114
201011104221
2011221541121
201212117056
201310134015
201411253015
20158178030
201611229012
20179177015
201814221019
20193178927
20206224259
20215135124
20226244159
202310236354
202482604 (1)64
20256163355
202662584—

More from Critikon Company, LLC

51 FDA decisions under this applicant name. See the company

  • K002248Dinamap Pro 1000 Monitor, Model 1000Critikon Company, LLC · 2000
  • K000500Dinamap Advanced Nibp ModuleCritikon Company, LLC · 2000
  • K992638Dinamap Pro Series Monitor, Models 100, 200, 300, 400Critikon Company, LLC · 2000
  • K982342Dinamap MPS Select Portable MonitorCritikon Company, LLC · 1998
  • K942700Dinamap Vital Signs Monitor Models 9300 and 9320/9340Critikon Company, LLC · 1995

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https://510kreport.com/device/K943709 · printed Nov 5, 2026

Cite this page

510(k) Report. “K943709: Dinamap Plus Vital Signs Monoitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K943709

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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