# K121026: Flo-Guard Breathing Filter

- Pathway: 510(k) (Traditional)
- Applicant: Intersurgical, Inc.
- Decided: Nov 2, 2012 after 212 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
Longest line of descent: 1 generation back to K973797 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973797: Breathing Circuit Bacterial Filter, King Systems Corp. (1998) Summary page 2.

## Indications for use
The Intersurgical Flo - Guard Breathing Filter is for use at machine end connections in home and hospital breathing system applications. It is designed to reduce bacterial/viral transmissions in order to protect the patient and respiratory equipment. The filter is single patient use for an adult target patient population, is intended for use within breathing systems in healthcare and home environments where ventilation is required and a maximum duration of 24 hours.

Source page: https://510kreport.com/device/K121026
Methodology: https://510kreport.com/methodology