# K160764: AirLife Autofill Humidification Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion 2200, Inc.
- Decided: Aug 25, 2016 after 157 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934140 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934140: MR290 Humidification Chamber Single Use, Fisher & Paykel Electronics, Ltd. (1994) Summary page 4.

## Recalls of this device
- Nov 29, 2014 · Class I · Z-0345-2018: Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water e
- Nov 29, 2014 · Class I · Z-0346-2018: Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water e
- Nov 29, 2014 · Class I · Z-0343-2018: Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water e
- Nov 29, 2014 · Class I · Z-0344-2018: Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water e

## Indications for use
The AirLife Autofill Humidification Chamber is intended to hold water required to humidify breathing gases delivered to any patient using a heated humidifier. The product is single use device, non-sterile and used in professional healthcare environments under a doctor’s supervision and by skilled clinician. The AirLife Autofill Humidification Chamber is compatible with the Fisher and Paykel MR850 system.

Source page: https://510kreport.com/device/K160764
Methodology: https://510kreport.com/methodology