# K973797: Breathing Circuit Bacterial Filter

- Pathway: 510(k) (Traditional)
- Applicant: King Systems Corp.
- Decided: Mar 12, 1998 after 157 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K121026: Flo-Guard Breathing Filter (2012), 0 descendants of its own

## Recalls of this device
- Mar 15, 2017 · Class II · Z-0321-2018: Potential for leak test failures.

## Indications for use
A bacterial filter is indicated for use when the care provider desires to protect the patient, care provider, equipment, or all three from the transference of bacteria or virus through the breathing circuit. This filter is provided only in combination with a King Systems Universal F2™ breathing circuit. Within this combination the overall intended use is to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.

Source page: https://510kreport.com/device/K973797
Methodology: https://510kreport.com/methodology