Chrysalis Intelligence · Sponsors · Pulmonx Corporation

Pulmonx Corporation

Redwood City, CA, US · 3 510(k) clearances · 14 PMAs · 1 recalls

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Total clearances
3
2021-09-02 → 2026-02-13
Last 12 months
1
Product codes
2
Most recent
2026-02-13
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) Class II Anesthesiology 2 2026-02-13
JAK System, X-Ray, Tomography, Computed Class II Radiology 1 2021-09-02
Class III

PMA approvals (14)

Total PMA records
14
Originals + supplements
Distinct product codes
1
First decision
2020-10-06
Most recent
2026-06-17
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-06-17 P180002-S031 Zephyr Endobronchial Valve (EBV) System 30-Day Notice NJK Valve, Pulmonary Unknown
2026-03-17 P180002-S030 Zephyr Endobronchial Valve (EBV) System 30-Day Notice NJK Valve, Pulmonary Unknown
2024-12-04 P180002-S029 Zephyr Endobronchial Valve System Real-Time Process NJK Valve, Pulmonary Unknown
2024-08-23 P180002-S028 Zephyr Endobronchial Valve (EBV) System 30-Day Notice NJK Valve, Pulmonary Unknown
2024-05-13 P180002-S027 Zephyr Endobronchial Valve System Real-Time Process NJK Valve, Pulmonary Unknown
2024-03-22 P180002-S025 Zephyr Endobronchial Valve System Normal 180 Day Track No User Fee NJK Valve, Pulmonary Unknown
2024-03-01 P180002-S026 Zephyr Endobronchial Valve (EBV) System 30-Day Notice NJK Valve, Pulmonary Unknown
2023-09-05 P180002-S024 modified 4.0-LP funnel component Real-Time Process NJK Valve, Pulmonary Unknown
2023-03-25 P180002-S022 Zephyr Valve Reigstry (ZEVR) Normal 180 Day Track No User Fee NJK Valve, Pulmonary Unknown
2022-03-09 P180002-S020 Zephyr Valve Registry (ZEVR) Normal 180 Day Track No User Fee NJK Valve, Pulmonary Unknown
2021-08-13 P180002-S019 Zephyr Endobronchial Valve (Zephyr Valve) Normal 180 Day Track No User Fee NJK Valve, Pulmonary Unknown
2020-11-19 P180002-S017 Zephyr Endobronchial Valve System 30-Day Notice NJK Valve, Pulmonary Unknown
2020-10-30 P180002-S016 Zephyr Endobronchial Valve (EBV) System 30-Day Notice NJK Valve, Pulmonary Unknown
2020-10-06 P180002-S015 Zephyr Endobronchial Valve (EBV) System 135 Review Track For 30-Day Notice NJK Valve, Pulmonary Unknown
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2023-08-31
DateSeverityStatusRecall # ProductCodeReason
2023-08-31 Class II Ongoing Z-0235-2024 Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP — 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.
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2026-02-13 K253096 Chartis Precision Catheter CBI Class II Anesthesiology
2022-12-01 K222340 Chartis Precision Catheter CBI Class II Anesthesiology
2021-09-02 K212494 Lung Image Analysis JAK Class II Radiology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence