510(k) Report

510(k) · Cleared

Cleared

Hewlett-Packard Model M1026A Anesthetic Gas Module

K951127510(k) TraditionalCleared Mar 24, 199511-day reviewClass II21 CFR 868.1400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hewlett-Packard GmbH · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Cleared on Mar 24, 1995 after an 11-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 446 later devices descend from it.

Decided
Mar 24, 1995
Review
11 days
Class
Class II
Product code
CCK
Recalls
None
Predicates
0

446 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2004: 12 descendants cleared2002: 4 descendants cleared1998: 1 descendant cleared2000: 1 descendant cleared2003: 6 descendants cleared2008: 17 descendants cleared2012: 19 descendants cleared2006: 18 descendants cleared2011: 22 descendants cleared2007: 7 descendants cleared2010: 20 descendants cleared2005: 9 descendants cleared2009: 19 descendants cleared2014: 15 descendants cleared2013: 17 descendants cleared2015: 15 descendants cleared2016: 17 descendants cleared2017: 19 descendants cleared2018: 25 descendants cleared2025: 29 descendants cleared2026: 21 descendants cleared2021: 21 descendants cleared2020: 14 descendants cleared2023: 26 descendants cleared2022: 30 descendants cleared2019: 17 descendants cleared2024: 24 descendants cleared1995200020052010201520202025
  1. This deviceK951127 Hewlett-Packard Model M1026A Anesthetic Gas ModuleHewlett-Packard GmbH · 1995
  2. Descendant · cites it directly · 426 of its ownK982619 HP Anesthesia Gas Monitor (Watertrap), Model A02Hewlett-Packard Co. · 1998
  3. Descendant · cites it directly · 425 of its ownK994188 Modification to Agilent Technologies Anesthesia Gas Monitor, Model…Agilent Technologies, GmbH · 2000
  4. Descendant · cites it directly · 421 of its ownK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
  5. Descendant · 2 generations on · 407 of its ownK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  6. Descendant · 3 generations on · 406 of its ownK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002

Showing 5 of 446 descendants. See all descendants

Descendants cleared per year

1997: 11998: 12000: 12002: 42003: 62004: 122005: 92006: 182007: 72008: 172009: 192010: 202011: 222012: 192013: 172014: 152015: 152016: 172017: 192018: 252019: 172020: 142021: 212022: 302023: 262024: 242025: 292026: 21
1997high 30 (2022) · low 0 (1999)2026

Most influential descendants

Showing 5 of 446 · See all
  • K982619HP Anesthesia Gas Monitor (Watertrap), Model A02Hewlett-Packard Co. · 1998 · cites it directly426descendants
  • K994188Modification to Agilent Technologies Anesthesia Gas Monitor, Model M1026A #CO5Agilent Technologies, GmbH · 2000 · cites it directly425descendants
  • K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems · 2002 · cites it directly421descendants
  • K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002 · 2 generations on407descendants
  • K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient…Philips Medical Systems · 2002 · 3 generations on406descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951127Hewlett-Packard Model M1026A Anesthetic Gas ModuleHewlett-Packard GmbH1995—
+1K982619HP Anesthesia Gas Monitor (Watertrap), Model A02Hewlett-Packard Co.1998—
+1K994188Modification to Agilent Technologies Anesthesia Gas Monitor, Model M1026A #CO5Agilent Technologies, GmbH2000—
+1K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems2002—
+2K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
+3K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
200010
200240
200360
2004120
200590
2006180
200770
2008170
2009190
2010200
2011220
2012190
2013170
2014150
2015150
2016170
2017190
2018250
2019170
2020140
2021210
2022300
2023260
2024240
2025290
2026210
FIG. 1 — Lineage of K951127, 1995–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CCK? 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 CCK device

  1. #1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (446)

See all 446

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K982619HP Anesthesia Gas Monitor (Watertrap), Model A02Hewlett-Packard Co.1998426
K994188Modification to Agilent Technologies Anesthesia Gas Monitor, Model M1026A #CO5Agilent Technologies, GmbH2000425
K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems2002421
K040917Philips Anesthesia Gas Monitor, Model M1026BPhilips Medizin Systeme Boeblingen GmbH2004252
K965062Siemens SC9000/SC9015 Multigas and Multigas+ ModulesSiemens Medical Solutions USA, Inc.199718

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?

  • Of its descendants, K982619 (Hewlett-Packard Co., 1998) has gone furthest, with 426 descendants of its own.

How does its category compare?

All CCK devices

CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CCK

3in 2025

2007: 52008: 32009: 32010: 32011: 22012: 72013: 42014: 92015: 52016: 22017: 52018: 62019: 72020: 42021: 42022: 32023: 42024: 32025: 32026 (partial year): 3
2007high 9 (2014) · low 2 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CCK

169in 2025

2007: 56 days median2008: 248 days median2009: 101 days median2010: 125 days median2012: 150 days median2013: 132 days median2014: 166 days median2015: 105 days median2017: 134 days median2018: 296 days median2019: 261 days median2020: 188 days median2021: 227 days median2022: 226 days median2023: 555 days median2024: 592 days median2025: 169 days median2026 (partial year): 224 days median
2007high 592 (2024) · low 56 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CCK

1in 2022

2008: 12009: 192010: 42011: 142012: 32013: 2, 1 Class I2015: 12018: 52019: 7, 7 Class I2020: 12022: 1
2007high 19 (2009) · low 0 (2007)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · CCK

1,259in 2025

2007: 72008: 202009: 212010: 122011: 182012: 132013: 282014: 512015: 1142016: 882017: 582018: 632019: 1412020: 2,3022021: 2,2722022: 2,4752023: 1,6372024: 1,2162025: 1,259
2007high 2,475 (2022) · low 7 (2007)2025

MAUDE reports naming product code CCK, 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
200755607
20083248120
200931011921
20103125412
20112—1418
20127150313
201341322 (1)28
20149166051
201551051114
20162—088
20175134058
20186296563
201972617 (7)141
2020418812,302
2021422702,272
2022322612,475
2023455501,637
2024359201,216
2025316901,259
202632240—

More from Hewlett-Packard GmbH

16 FDA decisions under this applicant name. See the company

  • K993383HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models M3000A, M3046A, M3015A, Rel.BHewlett-Packard GmbH · 20002 recalls
  • K992273HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor M3000A/M3046A/M3016A,Rel BHewlett-Packard GmbH · 2000
  • K992595HP Viridia Component Monitoring System, Model Rev. K with Easi-ST Segment Measurement, HP Viridia CMS 24/26…Hewlett-Packard GmbH · 1999
  • K992674HP Viridia CMS Patient Monitor with Eeg Parameter, Model M1027AHewlett-Packard GmbH · 1999
  • K990476HP Viridia Component Monitoring System, HP Viridia CMS 24/26, Model Rev. K with Easi-Ecg OptionHewlett-Packard GmbH · 1999

Recent decisions in CCK

The CCK category page

  • K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden Corporation · 2026
  • K261633VisuBreathAffirm Medical Technologies II, LLC · 2026
  • K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC · 2026
  • K250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd. · 2025
  • K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden Corporation · 2025

https://510kreport.com/device/K951127 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951127: Hewlett-Packard Model M1026A Anesthetic Gas Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951127

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026