# K062091: Porous Media Humidiflow Humidifier for Universal Humidification

- Pathway: 510(k) (Traditional)
- Applicant: Porous Media Corp.
- Decided: Aug 8, 2006 after 15 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991484 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991484: Airlife Bubble Humidifer, Model 002003 and 002006, Allegiance Healthcare Corp. (1999) Summary page 1.
- (no number) Salter Labs’ bubbler (part number REF 7600): named in the summary without a submission number

## Recalls of this device
- Apr 26, 2007 · Not classified · Z-0935-2007: 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 blad

## Indications for use
Humidifiers are defined as a device that is intended to add moisture to the breathing gases for administration to a patient.

Source page: https://510kreport.com/device/K062091
Methodology: https://510kreport.com/methodology