510(k) · Cleared
Recalled · 2010Philips Anesthesia Gas Monitor, Model M1026B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medizin Systeme Boeblingen GmbH · CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Cleared on Apr 29, 2004 as substantially equivalent to K951127 (Hewlett-Packard GmbH, 1995) and 2 other predicates after a 21-day review. Its family tree reaches back 3 generations to 1995. 252 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 29, 2004
- Review
- 21 days
- Class
- Class II
- Product code
- CBQ
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K951127 (1995). 252 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK951127 Hewlett-Packard Model M1026A Anesthetic Gas ModuleHewlett-Packard GmbH · 1995
- 2 generations backK982619 HP Anesthesia Gas Monitor (Watertrap), Model A02Hewlett-Packard Co. · 1998
- 1 generation backK994188 Modification to Agilent Technologies Anesthesia Gas Monitor, Model…Agilent Technologies, GmbH · 2000
- This deviceK040917 Philips Anesthesia Gas Monitor, Model M1026BPhilips Medizin Systeme Boeblingen GmbH · 2004
- Descendant · cites it directly · 251 of its ownK041956 Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004
- Descendant · 2 generations on · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- Descendant · 3 generations on · 247 of its ownK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- Descendant · 3 generations on · 234 of its ownK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- Descendant · 3 generations on · 233 of its ownK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
Showing 5 of 252 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 252 · See all- K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004 · cites it directly251descendants
- K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · 2 generations on249descendants
- K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · 3 generations on247descendants
- K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2005 · 3 generations on234descendants
- K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Philips Medizin Systeme Boeblingen GmbH · 2006 · 3 generations on233descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951127 | Hewlett-Packard Model M1026A Anesthetic Gas Module | Hewlett-Packard GmbH | 1995 | — |
| −2 | K982619 | HP Anesthesia Gas Monitor (Watertrap), Model A02 | Hewlett-Packard Co. | 1998 | — |
| −1 | K994188 | Modification to Agilent Technologies Anesthesia Gas Monitor, Model M1026A #CO5 | Agilent Technologies, GmbH | 2000 | — |
| 0 (this device) | K040917 | Philips Anesthesia Gas Monitor, Model M1026B | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| +1 | K041956 | Emg - Essential Gas Module, Model M1013A | Draeget Medical AG & Co. Kgaa | 2004 | — |
| +2 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| +3 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| +3 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| +3 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 11 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 8 | 0 |
| 2011 | 10 | 0 |
| 2012 | 9 | 0 |
| 2013 | 12 | 0 |
| 2014 | 11 | 0 |
| 2015 | 7 | 0 |
| 2016 | 12 | 0 |
| 2017 | 12 | 0 |
| 2018 | 15 | 0 |
| 2019 | 10 | 0 |
| 2020 | 10 | 0 |
| 2021 | 13 | 0 |
| 2022 | 19 | 0 |
| 2023 | 21 | 0 |
| 2024 | 18 | 0 |
| 2025 | 21 | 0 |
| 2026 | 13 | 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 CBQ? 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
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 |
|---|---|---|---|
| * | K951127 | Hewlett-Packard Model M1026A Anesthetic Gas ModuleSummary page 1…the gases classified under 868.1500, enflurane, and 868.1620, halothane. Analysis of these gases has been cleared under the original M1026B AGM 510(k) no. K951127 and K982619 3. The above device is substantially equivalent to the PhilipsM 1026A marketed pursuan… | 1995 |
| * | K982619 | HP Anesthesia Gas Monitor (Watertrap), Model A02Summary page 1…ified under 868.1500, enflurane, and 868.1620, halothane. Analysis of these gases has been cleared under the original M1026B AGM 510(k) no. K951127 and K982619 3. The above device is substantially equivalent to the PhilipsM 1026A marketed pursuant to K951127, K982619… | 1998 |
| * | K994188 | Modification to Agilent Technologies Anesthesia Gas Monitor, Model M1026A #CO5Summary page 1…) no. K951127 and K982619 3. The above device is substantially equivalent to the PhilipsM 1026A marketed pursuant to K951127, K982619, and K994188. Title: I Special 510(k) M1026B Company confidential page 115 of 162J DEPARTME… | 2000 |
What descends from it? (252)
See all 2523 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 21, 2010 | Not classified | Z-2265-2010 | Device Design | The manifold seal in the Philips M1657B Water Trap used on the Philips M1013A IntelliVue G1, M1019A, IntelliVue G5, and Anesthesia Gas Modules M1026B/BT may be unintentionally removed when changing the traps. A missing seal may result in… |
| Jul 21, 2010 | Not classified | Z-2266-2010 | Device Design | The manifold seal in the Philips M1657B Water Trap used on the Philips M1013A IntelliVue G1, M1019A, IntelliVue G5, and Anesthesia Gas Modules M1026B/BT may be unintentionally removed when changing the traps. A missing seal may result in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K041956 (Draeget Medical AG & Co. Kgaa, 2004) has gone furthest, with 251 descendants of its own.
- 4 other devices also cite its predicate K951127.
How does its category compare?
All CBQ devicesCBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBQ
FDA has decided no CBQ device since 2007.
Median 510(k) review, days · CBQ
Too few CBQ 510(k)s in any year since 2007 to give a median.
Recalls per year · CBQ
No recall names CBQ since 2007.
Adverse event reports per year · CBQ
1in 2022
MAUDE reports naming product code CBQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The M1026B Anesthesia Gas Module is intended to measure and monitor anesthesia gas contents in the ventilation circuitry of a patient and to provide this data to health care professionals in form readings, waves and alarms, via the Component Monitoring System, for the support of clinical decision making.
The device is indicated for use in health care facilities by health care professionals whenever there is a need for adult, pediatric and neonate patient anesthesia gas monitoring.
MR1 Compatibility Statement: The Ml 026B is not intended for use in a MRI magnetic field
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040917 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040917: Philips Anesthesia Gas Monitor, Model M1026B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040917
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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