# K223258: TNI Clear-Guard™ 3 angled breathing filter (1545020)

- Pathway: 510(k) (Traditional)
- Applicant: Intersurgical, Ltd.
- Decided: Jun 15, 2023 after 237 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
To be used only as part of the softFlow® 50 device to protect the patient, care provider, equipment, or all three from the transference of bacteria or virus through the breathing circuit. The filter should be positioned in a non-humidified gas flow.

Source page: https://510kreport.com/device/K223258
Methodology: https://510kreport.com/methodology