510(k) Report

510(k) · Cleared

Cleared

Dinamap Plus Physiological Monitor Model 8700

K912188510(k) TraditionalCleared Dec 4, 1991201-day reviewClass II21 CFR 870.1025

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

Critikon Company, LLC · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Dec 4, 1991 after a 201-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
Dec 4, 1991
Review
201 days
Class
Class II
Product code
MHX
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 cleared1990200020102020
  1. This deviceK912188 Dinamap Plus Physiological Monitor Model 8700Critikon Company, LLC · 1991
  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)K912188Dinamap Plus Physiological Monitor Model 8700Critikon Company, LLC1991—
+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 K912188, 1991–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 MHX device

  1. #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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 MHX devices

MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MHX

8in 2025

2007: 152008: 162009: 132010: 202011: 122012: 162013: 212014: 132015: 142016: 132017: 142018: 112019: 72020: 112021: 52022: 152023: 82024: 52025: 82026 (partial year): 14
2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007: 96 days median2008: 58 days median2009: 57 days median2010: 90 days median2011: 81 days median2012: 88 days median2013: 120 days median2014: 248 days median2015: 203 days median2016: 149 days median2017: 134 days median2018: 203 days median2019: 243 days median2020: 196 days median2021: 195 days median2022: 189 days median2023: 229 days median2024: 181 days median2025: 192 days median2026 (partial year): 205 days median
2007high 248 (2014) · low 57 (2009)2026

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

Recalls per year · MHX

21so far in 2026, the most since 2007

2007: 32008: 22009: 72010: 132011: 162012: 112013: 142014: 62015: 52016: 72017: 62018: 122019: 62022: 62023: 32024: 32025: 152026 (partial year): 21
2007high 21 (2026) · low 0 (2020)2026

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

Adverse event reports per year · MHX

3,761in 2025

2007: 1312008: 2322009: 3822010: 9552011: 9492012: 6762013: 1,9972014: 1,6092015: 1,2842016: 1,1052017: 1,1152018: 2,1572019: 1,4622020: 1,7142021: 2,4232022: 1,4702023: 2,2542024: 2,8142025: 3,761
2007high 3,761 (2025) · low 131 (2007)2025

MAUDE reports naming product code MHX, 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
200715963131
200816582232
200913577382
2010209013955
2011128116949
2012168811676
201321120141,997
20141324861,609
20151420351,284
20161314971,105
20171413461,115
201811203122,157
2019724361,462
20201119601,714
2021519502,423
20221518961,470
2023822932,254
2024518132,814
20258192153,761
20261420521—

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
  • K943709Dinamap Plus Vital Signs MonoitorCritikon Company, LLC · 1995

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https://510kreport.com/device/K912188 · printed Nov 6, 2026

Cite this page

510(k) Report. “K912188: Dinamap Plus Physiological Monitor Model 8700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912188

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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