510(k) Report

510(k) · Cleared

Cleared

Capnostat / Capnoflex CO2 System

K083750510(k) SpecialCleared Mar 23, 200996-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

Ge Medical Systems Information Technologies · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Mar 23, 2009 as substantially equivalent to K073462 (Ge Medical Systems Information Technologies, 2008) and 2 other predicates after a 96-day review. Its family tree reaches back 8 generations to 1996.

Decided
Mar 23, 2009
Review
96 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
3

Its longest line of descent runs back 8 generations to K963644 (1996). 33 ancestors in all, the oldest K900598 (1990). No later device cites it as a predicate yet.

  1. Root · 8 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
  2. 7 generations backK974496 A-2000 Eeg Monitor with BisAspect Medical Systems, Inc. · 1998
  3. 6 generations backK012466 Bis/Eeg ModuleGeneral Electric Medical Systems Information Techn · 2001
  4. 5 generations backK031694 Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2003
  5. 4 generations backK030267 Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2004
  6. 3 generations backK040183 BISXAspect Medical Systems, Inc. · 2004
  7. 2 generations backK051367 Patient Monitor, Models Dash 3000, 4000 and 5000Ge Medical Systems Information Technologies · 2005 · Recalled
  8. 1 generation backK073462 Modification to Dash 3000, 4000, 5000 Monitor and AccessoriesGe Medical Systems Information Technologies · 2008 · Recalled
  9. This deviceK083750 Capnostat / Capnoflex CO2 SystemGe Medical Systems Information Technologies · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K963644A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc.1996—
−7K974496A-2000 Eeg Monitor with BisAspect Medical Systems, Inc.1998—
−6K012466Bis/Eeg ModuleGeneral Electric Medical Systems Information Techn2001—
−5K031694Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc.2003—
−4K030267Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc.2004—
−3K040183BISXAspect Medical Systems, Inc.2004—
−2K051367Patient Monitor, Models Dash 3000, 4000 and 5000Ge Medical Systems Information Technologies20051
−1K073462Modification to Dash 3000, 4000, 5000 Monitor and AccessoriesGe Medical Systems Information Technologies20089
0 (this device)K083750Capnostat / Capnoflex CO2 SystemGe Medical Systems Information Technologies2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199020
199210
199310
199510
199610
199710
199830
199920
200030
200130
200230
200320
200410
200710
FIG. 1 — Lineage of K083750, 1996–2009Source: 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 MHX? 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? (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
*K073462Modification to Dash 3000, 4000, 5000 Monitor and Accessories
Summary page 1
…DQA - Oximeter DSB - Plethysmograph, Impedance GWQ - Electroencephalograph Predicate Device(s): K073462 - Dash 3000/4000/5000 Patient Monitor K071073 - Solar 8000M/i K030431…
Ge Medical Systems Information Technologies20089
*K071073Solar 8000 and Transport Pro with Patient Data Module
Summary page 1
…ance GWQ - Electroencephalograph Predicate Device(s): K073462 - Dash 3000/4000/5000 Patient Monitor K071073 - Solar 8000M/i K030431 - Dash 3000/4000/5000 Patient Monitor Device Description: The Ca…
Ge Medical Systems Information Technologies200713
*K030431Modification to Dash 3000/4000 Patient Monitor
Summary page 1
…alograph Predicate Device(s): K073462 - Dash 3000/4000/5000 Patient Monitor K071073 - Solar 8000M/i K030431 - Dash 3000/4000/5000 Patient Monitor Device Description: The Capnostat / CapnoFlex C02 System provides end-tidal C02…
Ge Medical Systems Information Technologies20031

Also cleared against K073462: 1 other device →

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 13 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
  • 13 of the 33 ancestors have a recall of any class.
  • 1 other device also cites its predicate K073462.

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. 2009, this device’s year, is highlighted.

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?

Dash 3000/4000/5000: The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited…

Read the full statement (366 words)

Dash 3000/4000/5000:

The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operator's manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORKTM indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs.

Solar 8000M/i:

The Solar 8000M/i patient monitoring system is a multi-parameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients. It provides uninterrupted monitoring of physiological patient data. The Solar 8000M/i patient monitoring system is capable of monitoring and analyzing the following parameters for all patient populations: electrocardiogram, invasive pressure, non-invasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous oxygen saturation, transcutaneous pO2 anfd pCO2, C02 and respiratory mechanics. The Solar 8000M/i patient monitoring system is capable of monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations, 02, impedance cardiography, electroencephalography and bispectral index. The Solar 8000MI/i patient monitoring system interfaces with a variety of third-party peripheral medical devices that support serial and/or analog data outputs. Information from these devices can be displayed, trended and stored in the monitoring system. The Solar 8000M/i patient monitoring system also provides physiological data over the UNITY NETWORK TM .

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K083750: Capnostat / Capnoflex CO2 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083750

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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