# K132143: Exhalation Valve

- Pathway: 510(k) (Traditional)
- Applicant: Intersurgical Incorporated
- Decided: Jun 4, 2014 after 328 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: 1 generation back to K984481 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984481: Exhalation Valve, Intersurgical, Inc. (1999) Summary page 1.

## Most influential descendants
- K210992: Altech® Exhalation Valve (Single Limb and Dual Limb) (2021), 0 descendants of its own

## Indications for use
The exhalation valves are used to control Inspiratory pressure and expel the expired air from a patient being venilated via a single limb breathing system. The exhalation valve arid single limb breathing systems are used with adults/pediatrics and prescribed by n Physician. A pediatric population is defined as 10 kg to 40 kg in weight. The product is not for use in neonates. The device can be used within hospitals and for home care use. It is a single patient use device and can be used for a maximum of 30 days.

Source page: https://510kreport.com/device/K132143
Methodology: https://510kreport.com/methodology