# K062664: Humidcare Heated Humidifier, Model 9S-004

- Pathway: 510(k) (Traditional)
- Applicant: Apex Medical Corp.
- Decided: Dec 6, 2006 after 90 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; 1 cites 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
- K120035: Apex Medical Ich Cpap Series (9S-007XXX) (2012), 2 descendants of its own
- K141522: Apex Medical Corp. Ich Cpap with Pva 9S-007XXX Series (2014), 1 descendant of its own
- K150111: Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series (2015), 0 descendants of its own

## Indications for use
HumidCare Heated Humidifier is for use with Apex Medical Corp.'s CPAP 9S-003 system. It is designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat that some people may experience.

Source page: https://510kreport.com/device/K062664
Methodology: https://510kreport.com/methodology