# K915460: Heated Respiratory Humidifier HC100

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Electronics, Ltd.
- Decided: Jan 15, 1993 after 408 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.
117 later devices descend from it; 3 cite it directly.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K973161: Cpap Humidifier (HC 200) (1998), 110 descendants of its own
- K040941: Cpap Humidifier, Model HC234 (and Related Accessories) (2004), 98 descendants of its own
- K041900: HC604 Cpap Humidifier (2004), 74 descendants of its own
- K082605: Vpap Auto with Humidaire 3I (2009), 33 descendants of its own
- K091947: S8 Aspen with H4I Plus (2009), 31 descendants of its own

Source page: https://510kreport.com/device/K915460
Methodology: https://510kreport.com/methodology