510(k) Report

510(k) · Cleared

Cleared

Heated Jet Humidifier Model Ams-1020

K863154510(k) TraditionalCleared Jan 12, 1987150-day reviewClass II21 CFR 868.5450

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 · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

Cleared on Jan 12, 1987 after a 150-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
Jan 12, 1987
Review
150 days
Class
Class II
Product code
BTT
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 deviceK863154 Heated Jet Humidifier Model Ams-1020Acutronic 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)K863154Heated Jet Humidifier Model Ams-1020Acutronic 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 K863154, 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 BTT? 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 BTT device

  1. #1 K222197 F&P Optiflow Junior 2/2+ Nasal Cannula…score 16.8 · 10 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 BTT devices

BTT Humidifier, Respiratory Gas, (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BTT

4in 2025

2007: 62008: 42009: 12010: 42011: 32012: 22013: 62014: 72015: 12016: 32017: 32018: 22019: 12020: 22021: 22022: 32023: 72024: 72025: 42026 (partial year): 4
2007high 7 (2014) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BTT

104in 2025

2007: 73 days median2008: 199 days median2010: 113 days median2011: 116 days median2013: 171 days median2014: 231 days median2016: 157 days median2017: 303 days median2022: 290 days median2023: 258 days median2024: 219 days median2025: 104 days median2026 (partial year): 184 days median
2007high 303 (2017) · low 73 (2007)2026

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

Recalls per year · BTT

1in 2025

2007: 12008: 12010: 22011: 12014: 5, 4 Class I2025: 12026 (partial year): 1
2007high 5 (2014) · low 0 (2009)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · BTT

1,743in 2025

2007: 3652008: 4562009: 5582010: 5622011: 6652012: 5832013: 7182014: 7182015: 6702016: 1,0942017: 1,0072018: 9182019: 8942020: 1,1882021: 1,5102022: 7492023: 7162024: 5012025: 1,743
2007high 1,743 (2025) · low 365 (2007)2025

MAUDE reports naming product code BTT, 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
20076731365
200841991456
20091—0558
201041132562
201131161665
20122—0583
201361710718
201472315 (4)718
20151—0670
2016315701,094
2017330301,007
20182—0918
20191—0894
20202—01,188
20212—01,510
202232900749
202372580716
202472190501
2025410411,743
202641841—

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

Recent decisions in BTT

The BTT category page

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  • K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited. · 2026
  • K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V. · 2026
  • K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd. · 2025

https://510kreport.com/device/K863154 · printed Nov 4, 2026

Cite this page

510(k) Report. “K863154: Heated Jet Humidifier Model Ams-1020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K863154

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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