# K983920: Ems Peep Valves- Adjustable

- Pathway: 510(k) (Traditional)
- Applicant: Engineered Medical Systems
- Decided: Jan 22, 1999 after 79 days
- Product code: BYE (Attachment, Breathing, Positive End Expiratory Pressure)
- Device class: 2
- Regulation: 21 CFR 868.5965
- 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 K923976 (1993). 2 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932799: Single Use Manual Resuscitator Peep Valve, Engineered Medical Systems (1993) Summary page 1.
- K923976: Ambu Single Patient Use Peep Valve, Ambu, Inc. (1993) Summary page 1.
- (no number) Intertech - PEEP: named in the summary without a submission number

## Most influential descendants
- K071560: Provent Nasal Dilator, Model BR2 (2008), 10 descendants of its own
- K111549: Attune Sleep Apnea System (2012), 5 descendants of its own
- K122130: Winx Sleep Therapy System (2012), 3 descendants of its own
- K090398: Provent Professional Sleep Apnea Therapy (2009), 3 descendants of its own
- K130538: Winx Sleep Therapy System (2013), 2 descendants of its own

## Indications for use
Indicated as an accessory to provide positive end expiratory pressure breathing capabilities to manual resuscitator, therapeutic CPAP systems, ventilator circuits. Available in 19mm, 22mm and 30 mm fittings. Pressure range from 0 to 20 cm H₂O

Source page: https://510kreport.com/device/K983920
Methodology: https://510kreport.com/methodology