# K983817: Breathing Circuit Bacterial Filter/Heat and Moisture Exchanger (Hme/F)

- Pathway: 510(k) (Traditional)
- Applicant: King Systems Corp.
- Decided: Mar 1, 1999 after 123 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
1. A breathing circuit bacterial filter is a device that is intended to remove micrabiological and particulate matter from the gases in the breathing circuit. 2. A Heat and Moisture Exchanger (HME) is a device intended to be positioned over a tracheotomy or tracheal tube to warm and humidify by passive means gases breathed in by a patient during anesthesia and ventilator care.

Source page: https://510kreport.com/device/K983817
Methodology: https://510kreport.com/methodology