Cleared Traditional

PnueAira (PNCU-01)

K251086 · Biotab, LLC · Cardiovascular
Aug 2025
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K251086 is an FDA 510(k) clearance for the PnueAira (PNCU-01), a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Biotab, LLC (St. Louis, US). The FDA issued a Cleared decision on August 18, 2025, 131 days after receiving the submission on April 9, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K251086 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2025
Decision Date August 18, 2025
Days to Decision 131 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code JOW — Sleeve, Limb, Compressible
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5800

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