510(k) Report

510(k) · Cleared

Cleared

Vital Signs Monitor

K101602510(k) SpecialCleared Sep 1, 201085-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

Criticare Systems, Inc. · MLD Monitor, St Segment With Alarm

Cleared on Sep 1, 2010 as substantially equivalent to K012059 (Criticare Systems, Inc., 2001) and 2 other predicates after an 85-day review. Its family tree reaches back 4 generations to 1995.

Decided
Sep 1, 2010
Review
85 days
Class
Class II
Product code
MLD
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K944860 (1995). 7 ancestors in all, the oldest K942737 (1995). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor2001: 1 other ancestor1995: 1 other ancestorK944860 · Scholar Patient Monitor · Criticare Systems, Inc. · 1995K022435 · 507EL Vital Signs Monitor · Criticare Systems, Inc. · 2002K051038 · 506 Patient Monitor · Ciriticare Systems, Inc. · 2005K091050 · 506CN Patient Monitor · Criticare Systems, Inc. · 20091995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor K091050 · 506CN Patient Monitor · Criticare Systems, Inc. · 2009K051038 · 506 Patient Monitor · Ciriticare Systems, Inc. · 2005K022435 · 507EL Vital Signs Monitor · Criticare Systems, Inc. · 2002K944860 · Scholar Patient Monitor · Criticare Systems, Inc. · 19950
  1. Root · 4 generations backK944860 Scholar Patient MonitorCriticare Systems, Inc. · 1995
  2. 3 generations backK022435 507EL Vital Signs MonitorCriticare Systems, Inc. · 2002
  3. 2 generations backK051038 506 Patient MonitorCiriticare Systems, Inc. · 2005
  4. 1 generation backK091050 506CN Patient MonitorCriticare Systems, Inc. · 2009
  5. This deviceK101602 Vital Signs MonitorCriticare Systems, Inc. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K944860Scholar Patient MonitorCriticare Systems, Inc.1995—
−3K022435507EL Vital Signs MonitorCriticare Systems, Inc.2002—
−2K051038506 Patient MonitorCiriticare Systems, Inc.2005—
−1K091050506CN Patient MonitorCriticare Systems, Inc.2009—
0 (this device)K101602Vital Signs MonitorCriticare Systems, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200110
200310
FIG. 1 — Lineage of K101602, 1995–2010Source: 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.

Planning a device in MLD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (3)

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
*K0120598100/8500 Vital Signs Monitor
Summary page 1
…with Alarm (MLD); Physiological Monitor (with Arrhythmia Detection or Alarms) (MHX) {CFR 870.1025} Substantial Equivalence is claimed to : 8100/8500 Vital Signs Monitor (K012059). 8100 w/Arrhythmia & ST Analysis Vital Signs Monitor (KO306 13). 9100 Vital Signs Monitor (K09 1050). Device Description: The 9…
Criticare Systems, Inc.2001—
*K030613Vital Signs Monitor W/Arrhythmia Detection and ST Analysis, Model 8100Criticare Systems, Inc.20031
*K091050506CN Patient Monitor
Summary page 1
…ubstantial Equivalence is claimed to : 8100/8500 Vital Signs Monitor (K012059). 8100 w/Arrhythmia & ST Analysis Vital Signs Monitor (KO306 13). 9100 Vital Signs Monitor (K09 1050). Device Description: The 91 00 monitor measures and displays real time physiological data of the patient, including a graphical…
Criticare Systems, Inc.2009—

Also cleared against K012059: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • 5 other devices also cite its predicate K012059.

How does its category compare?

All MLD devices

MLD Monitor, St Segment With Alarm: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · MLD

1in 2010

2008: 12010: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MLD

Too few MLD 510(k)s in any year since 2007 to give a median.

Recalls per year · MLD

No recall names MLD since 2007.

Adverse event reports per year · MLD

1in 2019

2007: 32008: 52009: 32010: 32011: 62012: 72014: 12015: 12017: 12018: 12019: 1
2007high 7 (2012) · low 0 (2013)2025

MAUDE reports naming product code MLD, 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
20070—03
20081—05
20090—03
20101—03
20110—06
20120—07
20130—00
20140—01
20150—01
20160—00
20170—01
20180—01
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.

The monitored parameters are:

1. ECG

2. Noninvasive Blood Pressure (NIBP)

3. Invasive Blood Pressure (IBP)

4. Temperature

5. Respiratory Gases

6. Anesthetic Agent Gases

7. Respiratory Rate

8. Pulse Oximetry (SpO2)

9. Arrhythmia and ST Analysis of the ECG waveforms

Indications for use as stated in the FDA summary.

Also cleared against K012059

5 other devices cite the same predicate.

  • K161420Moves SLCThornhill Research, Inc. · 2017
  • K093261MOVESThornhill Research, Inc. · 20102 Class I recalls
  • K081891Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc. · 2008
  • K0425698600 Vital Signs MonitorCriticare Systems, Inc. · 20043 recalls
  • K030613Vital Signs Monitor W/Arrhythmia Detection and ST Analysis, Model 8100Criticare Systems, Inc. · 20031 recall

More from Criticare Systems, Inc.

22 FDA decisions under this applicant name. See the company

  • K091050506CN Patient MonitorCriticare Systems, Inc. · 2009
  • K0425698600 Vital Signs MonitorCriticare Systems, Inc. · 20043 recalls
  • K030613Vital Signs Monitor W/Arrhythmia Detection and ST Analysis, Model 8100Criticare Systems, Inc. · 20031 recall
  • K022435507EL Vital Signs MonitorCriticare Systems, Inc. · 2002
  • K0120598100/8500 Vital Signs MonitorCriticare Systems, Inc. · 2001

Recent decisions in MLD

The MLD category page

  • K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems · 2008
  • K022740Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 & L-CICU02A SoftwareDatex-Ohmeda · 20022 recalls
  • K012837Modification to: Datex-Ohmeda Cardiocap 5 (Rev B) and AccessoriesDatex-Ohmeda · 20012 recalls
  • K002105Siemens Infinity SC 6002XL Enhanced with ST Segment AnalysisSiemens Medical Solutions USA, Inc. · 2000
  • K992323Datex-Ohmeda Cardiocap 5, F-MX, F-MXG and AccessoriesDatex-Ohmeda, Inc. · 19991 recall

https://510kreport.com/device/K101602 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101602: Vital Signs Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101602

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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