510(k) Report

510(k) · Cleared

Cleared

Modification to Agilent Technologies Anesthesia Gas Monitor, Model M1026A #CO5

K994188510(k) SpecialCleared May 19, 2000158-day reviewClass II21 CFR 868.1500

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

Agilent Technologies, GmbH · CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)

Cleared on May 19, 2000 as substantially equivalent to K951127 (Hewlett-Packard GmbH, 1995) and 1 other predicate after a 158-day review. Its family tree reaches back 2 generations to 1995. 425 later devices descend from it.

Decided
May 19, 2000
Review
158 days
Class
Class II
Product code
CBQ
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K951127 (1995). 425 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 12 descendants cleared2002: 3 descendants cleared2003: 5 descendants cleared2008: 14 descendants cleared2012: 19 descendants cleared2006: 17 descendants cleared2007: 7 descendants cleared2010: 20 descendants cleared2005: 9 descendants cleared2009: 19 descendants cleared2011: 20 descendants cleared2014: 15 descendants cleared2013: 17 descendants cleared2015: 14 descendants cleared2016: 16 descendants cleared2017: 17 descendants cleared2018: 25 descendants cleared2025: 29 descendants cleared2026: 20 descendants cleared2021: 18 descendants cleared2020: 14 descendants cleared2023: 26 descendants cleared2022: 28 descendants cleared2019: 17 descendants cleared2024: 24 descendants clearedK951127 · Hewlett-Packard Model M1026A Anesthetic Gas Module · Hewlett-Packard GmbH · 1995K982619 · HP Anesthesia Gas Monitor (Watertrap), Model A02 · Hewlett-Packard Co. · 19981995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 7 descendants3 generations forward: 60 descendants4 generations forward: 52 descendants5 generations forward: 63 descendants6 generations forward: 74 descendants7 generations forward: 66 descendants8 generations forward: 39 descendants9 generations forward: 22 descendants10 generations forward: 26 descendants11 generations forward: 13 descendants12 generations forward: 1 descendant K982619 · HP Anesthesia Gas Monitor (Watertrap), Model A02 · Hewlett-Packard Co. · 1998K951127 · Hewlett-Packard Model M1026A Anesthetic Gas Module · Hewlett-Packard GmbH · 19950+5+10
  1. Root · 2 generations backK951127 Hewlett-Packard Model M1026A Anesthetic Gas ModuleHewlett-Packard GmbH · 1995
  2. 1 generation backK982619 HP Anesthesia Gas Monitor (Watertrap), Model A02Hewlett-Packard Co. · 1998
  3. This deviceK994188 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
  7. Descendant · 3 generations on · 404 of its ownK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  8. Descendant · 3 generations on · 376 of its ownK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003

Showing 5 of 425 descendants. See all descendants

Descendants cleared per year

2002: 32003: 52004: 122005: 92006: 172007: 72008: 142009: 192010: 202011: 202012: 192013: 172014: 152015: 142016: 162017: 172018: 252019: 172020: 142021: 182022: 282023: 262024: 242025: 292026: 20
2002high 29 (2025) · low 3 (2002)2026

Most influential descendants

Showing 5 of 425 · See all
  • 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
  • K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…Philips Medical Systems, Inc. · 2003 · 3 generations on404descendants
  • K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH · 2003 · 3 generations on376descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K951127Hewlett-Packard Model M1026A Anesthetic Gas ModuleHewlett-Packard GmbH1995—
−1K982619HP Anesthesia Gas Monitor (Watertrap), Model A02Hewlett-Packard Co.1998—
0 (this device)K994188Modification 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—
+3K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
+3K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200350
2004120
200590
2006170
200770
2008140
2009190
2010200
2011200
2012190
2013170
2014150
2015140
2016160
2017170
2018250
2019170
2020140
2021180
2022280
2023260
2024240
2025290
2026200
FIG. 1 — Lineage of K994188, 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), 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
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What was it cleared against? (2)

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
*K951127Hewlett-Packard Model M1026A Anesthetic Gas Module
Summary page 1
…are similar to the gases classified under 868.1500, enflurane, and 868.1620, halothane. Analysis of these gases has been cleared under the original M1026A AGM 510(k) no. K951127 and K982619 3. The above device is substantially equivalent to the Agilent Technologies M1026A marketed pursuant to K951127 and…
Hewlett-Packard GmbH1995—
*K982619HP Anesthesia Gas Monitor (Watertrap), Model A02
Summary page 1
…to the gases classified under 868.1500, enflurane, and 868.1620, halothane. Analysis of these gases has been cleared under the original M1026A AGM 510(k) no. K951127 and K982619 3. The above device is substantially equivalent to the Agilent Technologies M1026A marketed pursuant to K951127 and K982619. |…
Hewlett-Packard Co.1998—

Also cleared against K951127: 4 other devices →

What descends from it? (425)

See all 425

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

NumberDeviceApplicantDecidedDescendants
K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems2002421
K040917Philips Anesthesia Gas Monitor, Model M1026BPhilips Medizin Systeme Boeblingen GmbH2004252

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 5 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K021300 (Philips Medical Systems, 2002) has gone furthest, with 421 descendants of its own.
  • 4 other devices also cite its predicate K951127.

How does its category compare?

All CBQ devices

CBQ 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

2010: 12012: 32015: 12019: 52020: 12022: 1
2007high 5 (2019) · low 0 (2007)2025

MAUDE reports naming product code CBQ, 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—00
20080—00
20090—00
20100—01
20110—00
20120—03
20130—00
20140—00
20150—01
20160—00
20170—00
20180—00
20190—05
20200—01
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The M1026A 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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K951127

4 other devices cite the same predicate.

  • K040917Philips Anesthesia Gas Monitor, Model M1026BPhilips Medizin Systeme Boeblingen GmbH · 20042 recalls
  • K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems · 2002
  • K982619HP Anesthesia Gas Monitor (Watertrap), Model A02Hewlett-Packard Co. · 1998
  • K965062Siemens SC9000/SC9015 Multigas and Multigas+ ModulesSiemens Medical Solutions USA, Inc. · 1997

More from Agilent Technologies, GmbH

2 FDA decisions under this applicant name. See the company

  • K000822Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement Server and Compact Portable…Agilent Technologies, GmbH · 2000

Recent decisions in CBQ

The CBQ category page

  • K040917Philips Anesthesia Gas Monitor, Model M1026BPhilips Medizin Systeme Boeblingen GmbH · 20042 recalls
  • K962648Ohmeda Model 5330 Anesthetic Agent MonitorOhmeda Medical · 1997
  • K931439Ohmeda Model 5330 Anesthetic MonitorOhmeda Medical · 1993
  • K926451Datascope Multinex IIDatascope Corp. · 1993
  • K923433AS/3 Anaesthesia Monitoring System Airway ModuleInstrumentarium Corp. · 1993

https://510kreport.com/device/K994188 · printed Nov 3, 2026

Cite this page

510(k) Report. “K994188: Modification to Agilent Technologies Anesthesia Gas Monitor, Model M1026A #CO5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K994188

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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