# P180007: Spiration® Valve System

- Pathway: PMA
- Applicant: Gyrus Acmi, Inc.
- Decided: Dec 3, 2018 after 301 days
- Product code: NJK (Valve, Pulmonary)
- Device class: 3
- Recalls of this device: 1 (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
- Dec 23, 2021 · Class II · Z-0551-2022: Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)

Source page: https://510kreport.com/device/P180007
Methodology: https://510kreport.com/methodology