# K923618: Peep Valve

- Pathway: 510(k) (Traditional)
- Applicant: International Respiratory Systems, Inc.
- Decided: Aug 3, 1992 after 13 days
- Product code: BYE (Attachment, Breathing, Positive End Expiratory Pressure)
- Device class: 2
- Regulation: 21 CFR 868.5965
- Recalls of this device: 3 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jan 15, 2019 · Class II · Z-2434-2020: A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant resuscitators t
- Jan 15, 2019 · Class II · Z-2436-2020: A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant resuscitators t
- Jan 15, 2019 · Class II · Z-2435-2020: A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant resuscitators t

Source page: https://510kreport.com/device/K923618
Methodology: https://510kreport.com/methodology