# K913367: Models MR410 & MR480 Respiratory Humidifier/Access

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Electronics, Ltd.
- Decided: Jun 25, 1992 after 337 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.
75 later devices descend from it; 1 cites it directly.
4 of 76 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
- K953392: HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) (1996), 74 descendants of its own
- K983112: Respiratory Humidifier, Model # MR850 (1998), 73 descendants of its own
- K020332: Respiratory Humidifier, Model MR850 (2003), 65 descendants of its own
- K033710: MR850 Respiratory Humidifier, Model MR850JHU (2004), 54 descendants of its own
- K073706: Respiratory Humidifier, Model MR850 (2008), 47 descendants of its own

Source page: https://510kreport.com/device/K913367
Methodology: https://510kreport.com/methodology