# K984481: Exhalation Valve

- Pathway: 510(k) (Traditional)
- Applicant: Intersurgical, Inc.
- Decided: Jan 29, 1999 after 44 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
No predicates in its family tree.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K132143: Exhalation Valve (2014), 1 descendant of its own
- K210992: Altech® Exhalation Valve (Single Limb and Dual Limb) (2021), 0 descendants of its own

## Indications for use
A one-way valve that prevents the escape of inspiratory gases and re-breathing of expired gases while providing a means of egress for expired gases. Fits all 22 male T-pieces and allows the use of a PEEP valve as the gases exit the valve via a 22 mm port. ISO connections: When assembling any connections use a push and twist action to ensure a secure fit. All ports should remain capped when not is use. Recommended Change: every 24 hours or more frequently if visible deterioration is observed. Single patient use. Non-conductive. Non-sterile. Do not autoclave. CAUTIONS: Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K984481
Methodology: https://510kreport.com/methodology