Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PnueAira (PNCU-01)

K-Number: K251086 · 2025-08-18

ApplicantBiotab, LLC
Decision Date2025-08-18
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PnueAira (PNCU-01) is a medical device manufactured by Biotab, LLC. It received FDA 510(k) clearance on 2025-08-18 under approval number K251086. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PnueAira (PNCU-01)?

PnueAira (PNCU-01) is a medical device that received FDA 510(k) clearance on 2025-08-18. It is manufactured by Biotab, LLC. The 510(k) number is K251086.

When was PnueAira (PNCU-01) approved by the FDA?

PnueAira (PNCU-01) received FDA 510(k) clearance on 2025-08-18, under approval number K251086.

What company makes PnueAira (PNCU-01)?

PnueAira (PNCU-01) is manufactured by Biotab, LLC.

What is the FDA product code for PnueAira (PNCU-01)?

The FDA product code for PnueAira (PNCU-01) is JOW.

Related Devices (Code: JOW)

K163055Reprocessed Kendall SCD Express Foot CuffCovidien K160180Intermittent Pneumatic Compression systemDaesung Maref Co., Ltd. K161105Reprocessed Compression GarmentsCovidien K160431ActiveCare HomeMedical Compression Systems (Dbn) , Ltd. K161346NormaTec PCD-T and PCD-BNormaTec Industries, LP K161209Cirona 6400Devon Medical Products

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑