510(k) · Cleared
Recalled · 2007Porous Media Humidiflow Humidifier for Universal Humidification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Porous Media Corp. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Aug 8, 2006 as substantially equivalent to K991484 (Allegiance Healthcare Corp., 1999) after a 15-day review. Its family tree reaches back 1 generation to 1999. It has been recalled once.
- Decided
- Aug 8, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- BTT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991484 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK991484 Airlife Bubble Humidifer, Model 002003 and 002006Allegiance Healthcare Corp. · 1999
- This deviceK062091 Porous Media Humidiflow Humidifier for Universal HumidificationPorous Media Corp. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991484 | Airlife Bubble Humidifer, Model 002003 and 002006 | Allegiance Healthcare Corp. | 1999 | — |
| 0 (this device) | K062091 | Porous Media Humidiflow Humidifier for Universal Humidification | Porous Media Corp. | 2006 | — |
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991484 | Airlife Bubble Humidifer, Model 002003 and 002006Summary page 1…ty to the patient gas. PREDICATE DEVICE The Porous Media HUMIDIFLOW™ is substantially equivalent to the Allegiance bubble humidifier (subject of premarket notification K991484) and Salter Labs’ bubbler (part number REF 7600) which has been on the market prior to 1976. PERFORMANCE TESTING Performance ch… | 1999 |
| * | — | Salter Labs’ bubbler (part number REF 7600) Named without a submission number | |
| † | K053388 | Model 840 Ventilator with Proportional Assist Ventilation Plus Software Option | 2006 |
| † | K043006 | Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605 | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 26, 2007 | Not classified | Z-0935-2007 | Other | The Intake filter of the Humidiflow kits may became detached from the module and fall onto the compressor cooling fan during patient treatment. (If the filter were to come in contact with the fan blades this could stop the fan from… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K991484.
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 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/K062091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062091: Porous Media Humidiflow Humidifier for Universal Humidification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062091
Report an extraction error
Are you the manufacturer?
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