# K993268: Mallinckrodt Dar Heated Wire Breathing Circuit

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Dar S.R.L.
- Decided: Apr 19, 2000 after 202 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). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942392: Airway Connector with Flex Tube, Mallinckrodt Medical (1994) Summary page 1.
- K962220: Heated Wire Circuits  for SCT 3000 Heated Humidifier, Marquest Medical Products, Inc. (1997) Summary page 1.
- K983112: Respiratory Humidifier, Model # MR850, Fisher & Paykel Healthcare, Ltd. (1998) Summary page 1.

## Indications for use
The MALLINCKRODT DAR Heated Wire Breathing Circuit is intended to warm breathing gases for adults, children, and infants undergoing anesthesia or mechanical ventilation within a health care facility.

Source page: https://510kreport.com/device/K993268
Methodology: https://510kreport.com/methodology