# K020700: PMH 5000 Heated Humidifier for Respiratory Therapy

- Pathway: 510(k) (Traditional)
- Applicant: Pegasus Research Corp.
- Decided: Apr 26, 2004 after 784 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K080149: Heater Base, Model PMH7000 (2008), 1 descendant of its own
- K132857: Respiratory Gas Humidifier (2014), 0 descendants of its own
- K070467: Health Mask (2007), 0 descendants of its own

## Indications for use
The PMH Humidifier is intended to add moisture and To warm the breathing gases for administration to a patient. The humidifier is intended for use with flows of 5 liters per Minute or more through the humidifier.

Source page: https://510kreport.com/device/K020700
Methodology: https://510kreport.com/methodology