510(k) Report

510(k) · Cleared

Cleared

Monsoon Critical Care Jet Ventilator and Accessories

K012691510(k) TraditionalCleared Dec 20, 2002493-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

Acutronic Medical Systems AG · CBK Ventilator, Continuous, Facility Use

Cleared on Dec 20, 2002 as substantially equivalent to K863155 (Acutronic Medical Systems AG, 1987) and 1 other predicate after a 493-day review. Its family tree reaches back 1 generation to 1987. 50 later devices descend from it.

Decided
Dec 20, 2002
Review
493 days
Class
Class II
Product code
CBK
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K863154 (1987). 2 ancestors in all. 50 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1987: 1 other ancestor2012: 2 descendants cleared2025: 8 descendants cleared2026: 5 descendants cleared2015: 4 descendants cleared2014: 3 descendants cleared2016: 2 descendants cleared2022: 10 descendants cleared2024: 7 descendants cleared2017: 3 descendants cleared2019: 2 descendants cleared2020: 3 descendants cleared2023: 1 descendant clearedK863154 · Heated Jet Humidifier Model Ams-1020 · Acutronic Medical Systems AG · 19871990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 10 descendants5 generations forward: 14 descendants6 generations forward: 9 descendants7 generations forward: 8 descendants8 generations forward: 1 descendant K863154 · Heated Jet Humidifier Model Ams-1020 · Acutronic Medical Systems AG · 19870+5
  1. Root · 1 generation backK863154 Heated Jet Humidifier Model Ams-1020Acutronic Medical Systems AG · 1987
  2. This deviceK012691 Monsoon Critical Care Jet Ventilator and AccessoriesAcutronic Medical Systems AG · 2002
  3. Descendant · cites it directly · 49 of its ownK111933 Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien · 2012
  4. Descendant · 2 generations on · 45 of its ownK121806 Beside Respiratory Patient Monitoring System Beside Resiratory…Covidien · 2012
  5. Descendant · 3 generations on · 40 of its ownK130320 Bedside Respiratory Patient Monitoring System, Bedside Respiratory…Covidien · 2014
  6. Descendant · 3 generations on · 29 of its ownK141518 Nellcor Bedside Respiratory Patient Monitoring SystemCovidien · 2015
  7. Descendant · 4 generations on · 23 of its ownK181956 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

2012: 22014: 32015: 42016: 22017: 32019: 22020: 32022: 102023: 12024: 72025: 82026: 5
2012high 10 (2022) · low 0 (2013)2026

Most influential descendants

Showing 5 of 50 · See all
  • K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien · 2012 · cites it directly49descendants
  • K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien · 2012 · 2 generations on45descendants
  • K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien · 2014 · 3 generations on40descendants
  • K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien · 2015 · 3 generations on29descendants
  • K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019 · 4 generations on23descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K863154Heated Jet Humidifier Model Ams-1020Acutronic Medical Systems AG1987—
0 (this device)K012691Monsoon Critical Care Jet Ventilator and AccessoriesAcutronic Medical Systems AG2002—
+1K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien2012—
+2K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient…Covidien2012—
+3K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient…Covidien2014—
+3K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien2015—
+4K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201430
201540
201620
201730
201920
202030
2022100
202310
202470
202580
202650
FIG. 1 — Lineage of K012691, 1987–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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
Get a 510(k) Report

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
*K863155Universal Jet Ventilator Model Ams-1000
Summary page 1
…Company: ACUTRONIC Medical Systems AG Device: AMs-1000 Universal Jet Ventilator 510(k) : K863155 Date Cleared: 8/15/86 Company: ACUTRONIC Medical Systems AG…
Acutronic Medical Systems AG1987—
*K863154Heated Jet Humidifier Model Ams-1020
Summary page 1
…Company: ACUTRONIC Medical Systems AG Device: AMs-1020 Heated Jet Humidifier 510(k) : K863 154 Date Cleared: 8/15/86 File: 510(k) Summary MONSOON Rev 3 Date: 07.08.2002…
Acutronic Medical Systems AG1987—

What descends from it? (50)

See all 50

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

NumberDeviceApplicantDecidedDescendants
K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien201249

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K111933 (Covidien, 2012) has gone furthest, with 49 descendants 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)—

What is it indicated for?

The Monsoon Universal Jet Ventilator is intended for use during bronchoscopy or laryngoscopy in a hospital or other clinical setting.

Indications for use as stated in the FDA summary.

More from Acutronic Medical Systems AG

12 FDA decisions under this applicant name. See the company

  • K012693Mistral Critical Care Jet Ventilator and AccessoriesAcutronic Medical Systems AG · 2002
  • K936009AMS 3000MAcutronic Medical Systems AG · 1995
  • K900744Ams 3000 Portable Jet VentilatorAcutronic Medical Systems AG · 1991
  • K900745VS-200S Jet VentilatorAcutronic Medical Systems AG · 1991
  • K883865External Jet Synchronizer, Model Ams-1010Acutronic Medical Systems AG · 1989

Recent decisions in CBK

The CBK category page

  • K253647Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa · 2026
  • K252663Inbentus VersatileIconic Solutions by Murcia, SL · 2026
  • K251888VPAP Pediatric Face MaskHsiner Co., Ltd. · 2026
  • K232365Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025
  • K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P…Fisher & Paykel Healthcare, Ltd. · 2025

https://510kreport.com/device/K012691 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012691: Monsoon Critical Care Jet Ventilator and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012691

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026