510(k) Report

510(k) · Cleared

Cleared

Universal Jet Ventilator Model Ams-1000

K863155510(k) TraditionalCleared Sep 28, 1987409-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 Sep 28, 1987 after a 409-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 51 later devices descend from it.

Decided
Sep 28, 1987
Review
409 days
Class
Class II
Product code
CBK
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2012: 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 cleared1990200020102020
  1. This deviceK863155 Universal Jet Ventilator Model Ams-1000Acutronic Medical Systems AG · 1987
  2. Descendant · cites it directly · 50 of its ownK012691 Monsoon Critical Care Jet Ventilator and AccessoriesAcutronic Medical Systems AG · 2002
  3. Descendant · 2 generations on · 49 of its ownK111933 Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien · 2012
  4. Descendant · 3 generations on · 45 of its ownK121806 Beside Respiratory Patient Monitoring System Beside Resiratory…Covidien · 2012
  5. Descendant · 4 generations on · 40 of its ownK130320 Bedside Respiratory Patient Monitoring System, Bedside Respiratory…Covidien · 2014
  6. Descendant · 4 generations on · 29 of its ownK141518 Nellcor Bedside Respiratory Patient Monitoring SystemCovidien · 2015

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2002: 12012: 22014: 32015: 42016: 22017: 32019: 22020: 32022: 102023: 12024: 72025: 82026: 5
2002high 10 (2022) · low 0 (2003)2026

Most influential descendants

Showing 5 of 51 · See all
  • K012691Monsoon Critical Care Jet Ventilator and AccessoriesAcutronic Medical Systems AG · 2002 · cites it directly50descendants
  • K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien · 2012 · 2 generations on49descendants
  • K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien · 2012 · 3 generations on45descendants
  • K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien · 2014 · 4 generations on40descendants
  • K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien · 2015 · 4 generations on29descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K863155Universal Jet Ventilator Model Ams-1000Acutronic Medical Systems AG1987—
+1K012691Monsoon Critical Care Jet Ventilator and AccessoriesAcutronic Medical Systems AG2002—
+2K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien2012—
+3K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient…Covidien2012—
+4K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient…Covidien2014—
+4K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
201220
201430
201540
201620
201730
201920
202030
2022100
202310
202470
202580
202650
FIG. 1 — Lineage of K863155, 1987–2026Source: 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 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? (51)

See all 51

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

NumberDeviceApplicantDecidedDescendants
K012691Monsoon Critical Care Jet Ventilator and AccessoriesAcutronic Medical Systems AG200250

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, K012691 (Acutronic Medical Systems AG, 2002) has gone furthest, with 50 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)—

More from Acutronic Medical Systems AG

12 FDA decisions under this applicant name. See the company

  • K012691Monsoon Critical Care Jet Ventilator and AccessoriesAcutronic Medical Systems AG · 2002
  • 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

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https://510kreport.com/device/K863155 · printed Nov 4, 2026

Cite this page

510(k) Report. “K863155: Universal Jet Ventilator Model Ams-1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K863155

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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