# K192713: Altera Filter and HME/Filter

- Pathway: 510(k) (Traditional)
- Applicant: Meditera Tibbi Malzeme San VE Tic AS
- Decided: Mar 16, 2020 after 171 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
Longest line of descent: 3 generations back to K941381 (1994). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151498: Breathing circuit bacterial/viral filter, Zhejiang Haisheng Medical Device Co., Ltd. (2015) Summary page 4.

## Most influential descendants
- K230483: Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) (2023), 0 descendants of its own

## Recalls of this device
- Jan 5, 2023 · Class III · Z-1160-2023: Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027"

## Indications for use
Filter only - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired. Use up to 24 hours. HME / Filter - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to maintain moisture levels in the patient’s respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation. Use up to 24 hours. Environment of use – clinical setting including hospital, sub-acute, pre-hospital and home For patient with Tidal Volumes > 300 ml.

Source page: https://510kreport.com/device/K192713
Methodology: https://510kreport.com/methodology