510(k) · Cleared
Recalled · Class I · 2014AirLife Autofill Humidification Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion 2200, Inc. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Aug 25, 2016 as substantially equivalent to K934140 (Fisher & Paykel Electronics, Ltd., 1994) after a 157-day review. Its family tree reaches back 1 generation to 1994. 1 of the 2 devices in its family, counting itself, has a Class I recall. It has been recalled 4 times, including 4 Class I recalls.
- Decided
- Aug 25, 2016
- Review
- 157 days
- Class
- Class II
- Product code
- BTT
- Recalls
- 4 (4 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934140 (1994). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK934140 MR290 Humidification Chamber Single UseFisher & Paykel Electronics, Ltd. · 1994
- This deviceK160764 AirLife Autofill Humidification ChamberCarefusion 2200, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934140 | MR290 Humidification Chamber Single Use | Fisher & Paykel Electronics, Ltd. | 1994 | — |
| 0 (this device) | K160764 | AirLife Autofill Humidification Chamber | Carefusion 2200, Inc. | 2016 | — |
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.
1 device in this family has 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 BTT device
- #1 K222197 F&P Optiflow Junior 2/2+ Nasal Cannula…score 16.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K934140 | MR290 Humidification Chamber Single UseSummary page 4…s: II Product Code: BTT 3. Predicate Device This submission demonstrates substantial equivalence to the MR290 Humidification Chamber, K934140 cleared on January 24, 1994. This predicate device has not been subject to a design-related recall. 4. Device Description… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 29, 2014 | Class I | Z-0345-2018 | Process control | Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the… |
| Nov 29, 2014 | Class I | Z-0346-2018 | Process control | Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the… |
| Nov 29, 2014 | Class I | Z-0343-2018 | Process control | Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the… |
| Nov 29, 2014 | Class I | Z-0344-2018 | Process control | Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 7 other devices also cite its predicate K934140.
How does its category compare?
All BTT devicesBTT Humidifier, Respiratory Gas, (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · BTT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTT
104in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTT
1in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · BTT
1,743in 2025
MAUDE reports naming product code BTT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 73 | 1 | 365 |
| 2008 | 4 | 199 | 1 | 456 |
| 2009 | 1 | — | 0 | 558 |
| 2010 | 4 | 113 | 2 | 562 |
| 2011 | 3 | 116 | 1 | 665 |
| 2012 | 2 | — | 0 | 583 |
| 2013 | 6 | 171 | 0 | 718 |
| 2014 | 7 | 231 | 5 (4) | 718 |
| 2015 | 1 | — | 0 | 670 |
| 2016 | 3 | 157 | 0 | 1,094 |
| 2017 | 3 | 303 | 0 | 1,007 |
| 2018 | 2 | — | 0 | 918 |
| 2019 | 1 | — | 0 | 894 |
| 2020 | 2 | — | 0 | 1,188 |
| 2021 | 2 | — | 0 | 1,510 |
| 2022 | 3 | 290 | 0 | 749 |
| 2023 | 7 | 258 | 0 | 716 |
| 2024 | 7 | 219 | 0 | 501 |
| 2025 | 4 | 104 | 1 | 1,743 |
| 2026 | 4 | 184 | 1 | — |
What is it indicated for?
The AirLife Autofill Humidification Chamber is intended to hold water required to humidify breathing gases delivered to
any patient using a heated humidifier. The product is single use device, non-sterile and used in professional healthcare
environments under a doctor’s supervision and by skilled clinician. The AirLife Autofill Humidification Chamber is
compatible with the Fisher and Paykel MR850 system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160764 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160764: AirLife Autofill Humidification Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160764
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026