510(k) Report

510(k) · Cleared

Cleared

Dinamap Compact Monitor

K970182510(k) TraditionalCleared Aug 18, 1997213-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

Johnson & Johnson Medical, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Aug 18, 1997 as substantially equivalent to K943709 (Critikon Company, LLC, 1995) and 3 other predicates after a 213-day review. Its family tree reaches back 1 generation to 1991. 1 of the 46 devices in its family, counting itself, has a Class I recall. 41 later devices descend from it.

Decided
Aug 18, 1997
Review
213 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K913695 (1991). 4 ancestors in all. 41 later devices descend from it, 1 citing it directly. 1 of the 46 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1995: 2 other ancestors1991: 1 other ancestor2000: 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 clearedK913695 · Nellcor (R) N-180 Pulse Oximeter · Nellcor, Inc. · 19911990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 6 descendants4 generations forward: 5 descendants5 generations forward: 5 descendants6 generations forward: 7 descendants7 generations forward: 5 descendants, 1 with a Class I recall18 generations forward: 6 descendants9 generations forward: 2 descendants K913695 · Nellcor (R) N-180 Pulse Oximeter · Nellcor, Inc. · 19910+5
  1. Root · 1 generation backK913695 Nellcor (R) N-180 Pulse OximeterNellcor, Inc. · 1991
  2. This deviceK970182 Dinamap Compact MonitorJohnson & Johnson Medical, Inc. · 1997
  3. Descendant · cites it directly · 40 of its ownK992638 Dinamap Pro Series Monitor, Models 100, 200, 300, 400Critikon Company, LLC · 2000
  4. Descendant · 2 generations on · 22 of its ownK014255 Dinamap Procare Series Monitor; Model 100, 200, 300, 400Ge Medical Systems Information Technologies · 2002
  5. Descendant · 3 generations on · 21 of its ownK022193 Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400NGe Medical Systems Information Technologies · 2002
  6. Descendant · 4 generations on · 20 of its ownK073203 Carescape V100Ge Medical Systems Information Technologies · 2007
  7. Descendant · 2 generations on · 13 of its ownK063055 VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

2000: 12002: 42006: 12007: 32009: 12010: 32012: 12013: 32014: 42015: 32016: 12017: 42018: 12019: 22020: 22021: 22022: 22024: 22025: 1
2000high 4 (2002) · low 0 (2001)2026

Class I recalls in this family

  • K133576 Monitor B407 generations on · 2014

Most influential descendants

Showing 5 of 41 · See all
  • 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
  • K063055VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · 2 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K913695Nellcor (R) N-180 Pulse OximeterNellcor, Inc.1991—
0 (this device)K970182Dinamap Compact MonitorJohnson & Johnson Medical, Inc.1997—
+1K992638Dinamap Pro Series Monitor, Models 100, 200, 300, 400Critikon Company, LLC2000—
+2K014255Dinamap Procare Series Monitor; Model 100, 200, 300, 400Ge Medical Systems Information Technologies2002—
+3K022193Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400NGe Medical Systems Information Technologies2002—
+4K073203Carescape V100Ge Medical Systems Information Technologies2007—
+2K063055VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200240
200610
200730
200910
201030
201210
201330
201441
201530
201610
201740
201810
201920
202020
202120
202220
202420
202510
FIG. 1 — Lineage of K970182, 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), 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 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? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K943709Dinamap Plus Vital Signs Monoitor
Summary page 2
…or the Compact Devices Monitor and its monitoring parameters and 510(k) numbers: Compact Predicate Device & Model 510(k) Number(s) System DINAMAP PLUS Monitor Model 9700 K943709 K912188 System DINAMAP X1 Monitor K942700 Temperature | DINAMAP XL Monitor K942700 NIBP DINAMAP PLUS Monitor Model 9700 K943709 '…
Critikon Company, LLC1995—
*K912188Dinamap Plus Physiological Monitor Model 8700
Summary page 2
…ompact Devices Monitor and its monitoring parameters and 510(k) numbers: Compact Predicate Device & Model 510(k) Number(s) System DINAMAP PLUS Monitor Model 9700 K943709 K912188 System DINAMAP X1 Monitor K942700 Temperature | DINAMAP XL Monitor K942700 NIBP DINAMAP PLUS Monitor Model 9700 K943709 ' K912188…
Critikon Company, LLC1991—
*K942700Dinamap Vital Signs Monitor Models 9300 and 9320/9340
Summary page 2
…itoring parameters and 510(k) numbers: Compact Predicate Device & Model 510(k) Number(s) System DINAMAP PLUS Monitor Model 9700 K943709 K912188 System DINAMAP X1 Monitor K942700 Temperature | DINAMAP XL Monitor K942700 NIBP DINAMAP PLUS Monitor Model 9700 K943709 ' K912188 DINAMAP XL Monitor K942700 Oximet…
Critikon Company, LLC1995—
*K913695Nellcor (R) N-180 Pulse Oximeter
Summary page 2
…0 Temperature | DINAMAP XL Monitor K942700 NIBP DINAMAP PLUS Monitor Model 9700 K943709 ' K912188 DINAMAP XL Monitor K942700 Oximetry Nellcor® Model N-180 Pulse Oximeter K913695 DINAMAP PLUS Monitor Model 9700 K943709 K912188 Continued on next page v-2 510(k) Summary, Continued Device De…
Nellcor, Inc.1991—

Also cleared against K943709: 1 other device →

What descends from it? (41)

See all 41

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K992638Dinamap Pro Series Monitor, Models 100, 200, 300, 400Critikon Company, LLC200040

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K992638 (Critikon Company, LLC, 2000) has gone furthest, with 40 descendants of its own.
  • 1 other device also cites its predicate K943709.

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—

What is it indicated for?

The DINAMAP Compact Monitor is intended to monitor a single adult, pediatric or neonatal patient’s vital signs at the bedside. Vital signs parameters include noninvasive blood pressure (systolic, diastolic and mean arterial pressure), pulse rate, temperature and/or oxygen saturation (pulse oximetry). The portable device is designed for use in numerous clinical settings, primarily in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor & delivery, endoscopy, cardiac step-down, etc. and can also be used during many specialized procedures in satellite areas, or in ambulatory surgery centers, physicians’ offices or alternate care settings.

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

Also cleared against K943709

1 other device cites the same predicate.

  • K955113Dinamap Select Multi-Parameter SystemJohnson & Johnson Medical, Inc. · 1996

More from Johnson & Johnson Medical, Inc.

54 FDA decisions under this applicant name. See the company

  • K001690Protectiv Safety Blood Collection NeedleJohnson & Johnson Medical, Inc. · 2000
  • K982641Advanced Nibp ModuleJohnson & Johnson Medical, Inc. · 1999
  • K983362NU-Gel * Wound DressingJohnson & Johnson Medical, Inc. · 1998
  • K982597Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
  • K974080Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 19981 recall

Recent decisions in MHX

The MHX category page

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https://510kreport.com/device/K970182 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970182: Dinamap Compact Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970182

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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