510(k) · Cleared
ClearedAirlife Bubble Humidifer, Model 002003 and 002006
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allegiance Healthcare Corp. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on May 13, 1999 after a 15-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- May 13, 1999
- Review
- 15 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK991484 Airlife Bubble Humidifer, Model 002003 and 002006Allegiance Healthcare Corp. · 1999
- Descendant · cites it directly · 3 of its ownK041963 American Bantex Humidifier, Dry, Bubble, Models B9000, 3 Psi and…American Bantex Corp. · 2004
- Descendant · cites it directly · 2 of its ownK113542 Salter Labs Bubble Humidifier (High Flow)Salter Labs, Arvin Facility · 2012
- Descendant · 2 generations on · 1 of its ownK161719 Salter Labs Bubble HumidifierSalter Labs · 2017
- Descendant · 3 generations on · 0 of its ownK230559 Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve…Medline Industries, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK062091 Porous Media Humidiflow Humidifier for Universal HumidificationPorous Media Corp. · 2006 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K041963American Bantex Humidifier, Dry, Bubble, Models B9000, 3 Psi and B9100, 6 PsiAmerican Bantex Corp. · 2004 · cites it directly3descendants
- K113542Salter Labs Bubble Humidifier (High Flow)Salter Labs, Arvin Facility · 2012 · cites it directly2descendants
- K161719Salter Labs Bubble HumidifierSalter Labs · 2017 · 2 generations on1descendant
- K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI®…Medline Industries, Inc. · 2023 · 3 generations on0descendants
- K062091Porous Media Humidiflow Humidifier for Universal HumidificationPorous Media Corp. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991484 | Airlife Bubble Humidifer, Model 002003 and 002006 | Allegiance Healthcare Corp. | 1999 | — |
| +1 | K041963 | American Bantex Humidifier, Dry, Bubble, Models B9000, 3 Psi and B9100, 6 Psi | American Bantex Corp. | 2004 | — |
| +1 | K113542 | Salter Labs Bubble Humidifier (High Flow) | Salter Labs, Arvin Facility | 2012 | — |
| +2 | K161719 | Salter Labs Bubble Humidifier | Salter Labs | 2017 | — |
| +3 | K230559 | Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230)… | Medline Industries, Inc. | 2023 | — |
| +1 | K062091 | Porous Media Humidiflow Humidifier for Universal Humidification | Porous Media Corp. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
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 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 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 |
|---|---|---|---|
| * | — | Airlife® Bubble Humidifiers Named without a submission number |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K041963 (American Bantex Corp., 2004) has gone furthest, with 3 descendants of its own.
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.
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?
Humidifiers are defined as a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient.
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/K991484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991484: Airlife Bubble Humidifer, Model 002003 and 002006.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991484
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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