510(k) Report

510(k) · Cleared

Cleared

Omicron Monitor, Delta Monitor

K960861510(k) TraditionalCleared Aug 19, 1996171-day reviewClass II21 CFR 868.5895

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

Core-M, Inc. · CBK Ventilator, Continuous, Facility Use

Cleared on Aug 19, 1996 after a 171-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Aug 19, 1996
Review
171 days
Class
Class II
Product code
CBK
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2001: 1 descendant cleared1995200020052010201520202025
  1. This deviceK960861 Omicron Monitor, Delta MonitorCore-M, Inc. · 1996
  2. Descendant · cites it directly · 1 of its ownK972848 Narkomed Mri Anesthesia SystemDraeger Medical, Inc. · 1997
  3. Descendant · 2 generations on · 0 of its ownK012446 Office Based Anesthesia Machine Mri, Model Oba-1 MriCharles A. Smith · 2001

Most influential descendants

Showing 2 of 2 · See all
  • K972848Narkomed Mri Anesthesia SystemDraeger Medical, Inc. · 1997 · cites it directly1descendant
  • K012446Office Based Anesthesia Machine Mri, Model Oba-1 MriCharles A. Smith · 2001 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K960861Omicron Monitor, Delta MonitorCore-M, Inc.1996—
+1K972848Narkomed Mri Anesthesia SystemDraeger Medical, Inc.1997—
+2K012446Office Based Anesthesia Machine Mri, Model Oba-1 MriCharles A. Smith2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200110
FIG. 1 — Lineage of K960861, 1996–2001Source: 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 CBK? 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 CBK device

  1. #1 K252663 Inbentus Versatilescore 16.0 · 17 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K972848Narkomed Mri Anesthesia SystemDraeger Medical, Inc.19971

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, K972848 (Draeger Medical, Inc., 1997) has gone furthest, with 1 descendant of its own.

How does its category compare?

All CBK devices

CBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CBK

4in 2025

2007: 112008: 182009: 122010: 142011: 132012: 172013: 52014: 52015: 72016: 42017: 62018: 42019: 82020: 52021: 62023: 52024: 92025: 42026 (partial year): 3
2007high 18 (2008) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CBK

163in 2025

2007: 142 days median2008: 115 days median2009: 122 days median2010: 150 days median2011: 192 days median2012: 207 days median2013: 277 days median2014: 439 days median2015: 266 days median2016: 323 days median2017: 280 days median2018: 183 days median2019: 435 days median2020: 176 days median2021: 267 days median2023: 309 days median2024: 203 days median2025: 163 days median2026 (partial year): 235 days median
2007high 439 (2014) · low 115 (2008)2026

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

Recalls per year · CBK

14in 2024

2007: 172008: 232009: 82010: 92011: 122012: 2, 1 Class I2013: 5, 2 Class I2014: 5, 4 Class I2015: 6, 4 Class I2016: 4, 1 Class I2017: 12018: 3, 3 Class I2019: 14, 13 Class I2020: 42021: 21, 19 Class I2022: 8, 4 Class I2023: 4, 3 Class I2024: 14, 14 Class I2026 (partial year): 15, 13 Class I
2007high 23 (2008) · low 0 (2025)2026

Class I (81 since 2007) Class II/III not classified

Adverse event reports per year · CBK

13,991in 2025

2007: 1,5312008: 1,9332009: 1,7662010: 1,7992011: 1,8772012: 5,5092013: 7,9212014: 7,6002015: 11,8762016: 16,0562017: 14,4512018: 9,8492019: 9,1002020: 11,0962021: 13,3222022: 15,9742023: 24,9282024: 20,3362025: 13,991
2007high 24,928 (2023) · low 1,531 (2007)2025

MAUDE reports naming product code CBK, 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
200711142171,531
200818115231,933
20091212281,766
20101415091,799
201113192121,877
2012172072 (1)5,509
201352775 (2)7,921
201454395 (4)7,600
201572666 (4)11,876
201643234 (1)16,056
20176280114,451
201841833 (3)9,849
2019843514 (13)9,100
20205176411,096
2021626721 (19)13,322
20220—8 (4)15,974
202353094 (3)24,928
2024920314 (14)20,336
20254163013,991
2026323515 (13)—

More from Core-M, Inc.

3 FDA decisions under this applicant name. See the company

  • K921978Breath Tracker (TM) Model 1800 Can-O-GaugeCore-M, Inc. · 1992
  • K892942Breath TrackerCore-M, Inc. · 1989

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https://510kreport.com/device/K960861 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960861: Omicron Monitor, Delta Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960861

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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