Cleared Traditional

eRapid with eTrack System

K251572 · Pari Respiratory Equipment, Inc. · Anesthesiology
Dec 2025
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K251572 is an FDA 510(k) clearance for the eRapid with eTrack System, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Pari Respiratory Equipment, Inc. (Midlothian, US). The FDA issued a Cleared decision on December 19, 2025, 211 days after receiving the submission on May 22, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K251572 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2025
Decision Date December 19, 2025
Days to Decision 211 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAF — Nebulizer (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5630

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