Cleared Traditional

K181424 - PeDIA (FDA 510(k) Clearance)

Class I Anesthesiology device.

K181424 · Pedia, LLC · Anesthesiology device
Sep 2018
Decision
117d
Days
Class 1
Risk

K181424 is an FDA 510(k) clearance for the PeDIA. Classified as Bag, Reservoir (product code BTC), Class I - General Controls.

Submitted by Pedia, LLC (Fairfax, US). The FDA issued a Cleared decision on September 25, 2018 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5320 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K181424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2018
Decision Date September 25, 2018
Days to Decision 117 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 225d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BTC Bag, Reservoir
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5320
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.