# P130008: Inspire II Upper Airway Stimulator

- Pathway: PMA
- Applicant: Inspire Medical Systems
- Decided: Apr 30, 2014 after 364 days
- Product code: MNQ (Stimulator, Hypoglossal Nerve, Implanted, Apnea)
- Device class: 3
- 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. PMA decisions do not claim a predicate device.

## Recalls of this device
- May 11, 2026 · Class II · Z-2515-2026: Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in un
- May 11, 2026 · Class II · Z-2516-2026: Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in un
- Jun 12, 2018 · Class II · Z-2969-2018: Incorrect use-by date on the device registration/patient file labels.

Source page: https://510kreport.com/device/P130008
Methodology: https://510kreport.com/methodology