510(k) Report

510(k) · Cleared

Cleared

Capnomac Ultima Anesthesia Monitor

K932098510(k) TraditionalCleared Nov 29, 1993210-day reviewClass II21 CFR 868.1850

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

Datex Division Instrumentarium Corp. · BZK Spirometer, Monitoring (W/Wo Alarm)

Cleared on Nov 29, 1993 after a 210-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 of the 321 devices in its family, counting itself, have a Class I recall. 320 later devices descend from it.

Decided
Nov 29, 1993
Review
210 days
Class
Class II
Product code
BZK
Recalls
None
Predicates
0

320 later devices descend from it, 2 citing it directly. 2 of the 321 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 1998: 1 descendant cleared2004: 5 descendants cleared2006: 12 descendants cleared2005: 7 descendants cleared2015: 13 descendants cleared2014: 16 descendants cleared, 1 with a Class I recall12007: 7 descendants cleared2019: 14 descendants cleared2012: 11 descendants cleared2013: 12 descendants cleared2009: 5 descendants cleared2011: 11 descendants cleared2010: 9 descendants cleared2016: 15 descendants cleared2017: 18 descendants cleared2008: 6 descendants cleared2018: 16 descendants cleared2023: 28 descendants cleared, 1 with a Class I recall12020: 14 descendants cleared2021: 19 descendants cleared2026: 18 descendants cleared2022: 22 descendants cleared2025: 22 descendants cleared2024: 19 descendants cleared1990200020102020
  1. This deviceK932098 Capnomac Ultima Anesthesia MonitorDatex Division Instrumentarium Corp. · 1993
  2. Descendant · cites it directly · 270 of its ownK040847 Modification to Vamos Anesthetic Gas MonitorDraeger Medical, Inc. · 2004
  3. Descendant · 2 generations on · 251 of its ownK041956 Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004
  4. Descendant · 3 generations on · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  5. Descendant · 4 generations on · 247 of its ownK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  6. Descendant · 4 generations on · 234 of its ownK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005

Showing 5 of 320 descendants. See all descendants

Descendants cleared per year

1998: 12004: 52005: 72006: 122007: 72008: 62009: 52010: 92011: 112012: 112013: 122014: 162015: 132016: 152017: 182018: 162019: 142020: 142021: 192022: 222023: 282024: 192025: 222026: 18
1998high 28 (2023) · low 0 (1999)2026

Class I recalls in this family

  • K133886 Perseus A5003 generations on · 2014
  • K230931 Atlan4 generations on · 2023

Most influential descendants

Showing 5 of 320 · See all
  • K040847Modification to Vamos Anesthetic Gas MonitorDraeger Medical, Inc. · 2004 · cites it directly270descendants
  • K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004 · 2 generations on251descendants
  • K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · 3 generations on249descendants
  • K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · 4 generations on247descendants
  • K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2005 · 4 generations on234descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932098Capnomac Ultima Anesthesia MonitorDatex Division Instrumentarium Corp.1993—
+1K040847Modification to Vamos Anesthetic Gas MonitorDraeger Medical, Inc.2004—
+2K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa2004—
+3K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
+4K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
+4K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200450
200570
2006120
200770
200860
200950
201090
2011110
2012110
2013120
2014161
2015130
2016150
2017180
2018160
2019140
2020140
2021190
2022220
2023281
2024190
2025220
2026180
FIG. 1 — Lineage of K932098, 1993–2026Source: 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.

2 devices in this family have a Class I recall. 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 BZK device

  1. #1 K260226 ElintMAX Respiratory Monitor (ElintMAX Monitor…score 19.5 · 26 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (320)

See all 320

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

NumberDeviceApplicantDecidedDescendants
K040847Modification to Vamos Anesthetic Gas MonitorDraeger Medical, Inc.2004270
K974581Millennia 3500 Series Monitor with Anthesthetic AgentInvivo Research, Inc.199858

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K133886Perseus A500Draeger Medical GmbH · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
  • K230931AtlanDrägerwerk AG Co. Kgaa · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 18 Class I recalls

What does this lineage say?

  • Of its descendants, K040847 (Draeger Medical, Inc., 2004) has gone furthest, with 270 descendants of its own.

How does its category compare?

All BZK devices

BZK Spirometer, Monitoring (W/Wo Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZK

2in 2019

2008: 12009: 32011: 12012: 12013: 12017: 12018: 22019: 22026 (partial year): 1
2007high 3 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZK

71in 2009

2009: 71 days median
2007high 71 (2009)2026

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

Recalls per year · BZK

2in 2011

2011: 2
2007high 2 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · BZK

2in 2020

2009: 12012: 12013: 732014: 312015: 122016: 12017: 12018: 12020: 2
2007high 73 (2013) · low 0 (2007)2025

MAUDE reports naming product code BZK, 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
20081—00
200937101
20100—00
20111—20
20121—01
20131—073
20140—031
20150—012
20160—01
20171—01
20182—01
20192—00
20200—02
20210—00
20220—00
20230—00
20240—00
20250—00
20261—0—

More from Datex Division Instrumentarium Corp.

55 FDA decisions under this applicant name. See the company

  • K953175AS/3 Estpr ModuleDatex Division Instrumentarium Corp. · 1997
  • K961247AS/3 Light MonitorDatex Division Instrumentarium Corp. · 1996
  • K943458AS/3 Airway ModuleDatex Division Instrumentarium Corp. · 1995
  • K945234AS/3 Memory Module, M0MEMDatex Division Instrumentarium Corp. · 1995
  • K933156Datex as/3 Patient MonitorDatex Division Instrumentarium Corp. · 1994

Recent decisions in BZK

The BZK category page

  • K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc. · 2026
  • K192584BEACON Caresystem Model 00002144Mermaid Care A/S · 2019
  • K192595ExSpiron 2XiRespiratory Motion · 2019
  • K180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018
  • K173181ExSpiron 1XiRespiratory Motion, Inc. · 2018

https://510kreport.com/device/K932098 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932098: Capnomac Ultima Anesthesia Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932098

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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