# K991926: OPAP

- Pathway: 510(k) (Traditional)
- Applicant: Opap, Inc.
- Decided: Oct 18, 1999 after 133 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- 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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The OPAP device is an individually molded mandibular repositioner mouthpiece / appliance that has an airway lumen and an integral oral chamber and exhaust port which facilitates application of positive airway pressure to treat obstructive sleep apnea. This device is indicated for use with CPAP and Bilevel systems. The OPAP facilitated delivery of CPAP and Bilevel is similar to nasal mask CPAP and Bilevel. Individual patients and specific problems may or may not be treated more effectively with the OPAP. Consult your sleep physician or dentist.

Source page: https://510kreport.com/device/K991926
Methodology: https://510kreport.com/methodology