# K210992: Altech® Exhalation Valve (Single Limb and Dual Limb)

- Pathway: 510(k) (Traditional)
- Applicant: Meditera Tibbi Malzeme San VE Tic AS
- Decided: Dec 23, 2021 after 265 days
- Product code: CBP (Valve, Non-Rebreathing)
- Device class: 2
- Regulation: 21 CFR 868.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K984481 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132143: Exhalation Valve, Intersurgical Incorporated (2014) Summary page 4.

## Indications for use
The exhalation valves are intended to be used in ventilator circuits consistent with the indicated use of the ventilator to which they are attached. The single limb model directs flow and allows for pressure monitoring and may be used within hospitals and for home care use. The dual limb model regulates flow and is for use in hospitals and for home care use. The exhalation valve are used with adults, pediatrics, and neonates. The exhalation valves are for single patient use and can be used for a maximum of 30 days

Source page: https://510kreport.com/device/K210992
Methodology: https://510kreport.com/methodology