# DEN170044: ClearMate

- Pathway: De Novo (Direct)
- Applicant: Thornhill Research, Inc.
- Decided: Mar 14, 2019 after 573 days
- Product code: QFB (Isocapnic Ventilation Device)
- Device class: 2
- Regulation: 21 CFR 868.5480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
ClearMateTM is intended to be used by emergency department medical professionals as an adjunctive treatment for patients suffering from carbon monoxide poisoning. The use of ClearMateTM enables accelerated elimination of carbon monoxide from the body by allowing isocapnic hyperventilation through simulated partial rebreathing.

Source page: https://510kreport.com/device/DEN170044
Methodology: https://510kreport.com/methodology