# P180002: Zephyr Endobronchial Valve System

- Pathway: PMA
- Applicant: Pulmonx Corporation
- Decided: Jun 29, 2018 after 178 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
- Aug 31, 2023 · Class II · Z-0235-2024: Endobronchial implant devices may have been labeled with a shortened expiration date but they can be used until the correct expiration date: 08 December 2024.

Source page: https://510kreport.com/device/P180002
Methodology: https://510kreport.com/methodology