# K993773: Humid-Heat

- Pathway: 510(k) (Traditional)
- Applicant: Hudson Rcj AB
- Decided: Sep 13, 2000 after 310 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
Longest line of descent: 3 generations back to K913368 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913368: Models MR700/MR720/MR730 Dual Servo Resp Humid Acc, Fisher & Paykel Electronics, Ltd. (1992) Summary page 1.
- K983112: Respiratory Humidifier, Model # MR850, Fisher & Paykel Healthcare, Ltd. (1998) Summary page 2.

## Indications for use
The Humid-Heat™ is an active respiratory humidifier that heats and humidifies dry breathing gases supplied from a ventilator via an endotracheal tube, a tracheostomy tube, or a face mask to adult patients under intensive care or anesthesia.

Source page: https://510kreport.com/device/K993773
Methodology: https://510kreport.com/methodology