510(k) · Cleared
ClearedCapnostat / Capnoflex CO2 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
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.
- Root · 8 generations backK963644 A-1000 Eeg Monitor and a-1050 Eeg MonitorAspect Medical Systems, Inc. · 1996
- 7 generations backK974496 A-2000 Eeg Monitor with BisAspect Medical Systems, Inc. · 1998
- 6 generations backK012466 Bis/Eeg ModuleGeneral Electric Medical Systems Information Techn · 2001
- 5 generations backK031694 Modification to Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2003
- 4 generations backK030267 Eeg Monitor with Bis, Model a-2000Aspect Medical Systems, Inc. · 2004
- 3 generations backK040183 BISXAspect Medical Systems, Inc. · 2004
- 2 generations backK051367 Patient Monitor, Models Dash 3000, 4000 and 5000Ge Medical Systems Information Technologies · 2005 · Recalled
- 1 generation backK073462 Modification to Dash 3000, 4000, 5000 Monitor and AccessoriesGe Medical Systems Information Technologies · 2008 · Recalled
- This deviceK083750 Capnostat / Capnoflex CO2 SystemGe Medical Systems Information Technologies · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K963644 | A-1000 Eeg Monitor and a-1050 Eeg Monitor | Aspect Medical Systems, Inc. | 1996 | — |
| −7 | K974496 | A-2000 Eeg Monitor with Bis | Aspect Medical Systems, Inc. | 1998 | — |
| −6 | K012466 | Bis/Eeg Module | General Electric Medical Systems Information Techn | 2001 | — |
| −5 | K031694 | Modification to Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2003 | — |
| −4 | K030267 | Eeg Monitor with Bis, Model a-2000 | Aspect Medical Systems, Inc. | 2004 | — |
| −3 | K040183 | BISX | Aspect Medical Systems, Inc. | 2004 | — |
| −2 | K051367 | Patient Monitor, Models Dash 3000, 4000 and 5000 | Ge Medical Systems Information Technologies | 2005 | 1 |
| −1 | K073462 | Modification to Dash 3000, 4000, 5000 Monitor and Accessories | Ge Medical Systems Information Technologies | 2008 | 9 |
| 0 (this device) | K083750 | Capnostat / Capnoflex CO2 System | Ge Medical Systems Information Technologies | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
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 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073462 | Modification to Dash 3000, 4000, 5000 Monitor and AccessoriesSummary page 1…DQA - Oximeter DSB - Plethysmograph, Impedance GWQ - Electroencephalograph Predicate Device(s): K073462 - Dash 3000/4000/5000 Patient Monitor K071073 - Solar 8000M/i K030431… | 2008 |
| * | K071073 | Solar 8000 and Transport Pro with Patient Data ModuleSummary 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… | 2007 |
| * | K030431 | Modification to Dash 3000/4000 Patient MonitorSummary 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… | 2003 |
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 devicesMHX 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
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
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.
https://510kreport.com/device/K083750 · printed Nov 4, 2026
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