Cleared Traditional

K181424 - PeDIA
(FDA 510(k) Clearance)

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

K181424 is an FDA 510(k) clearance for the PeDIA. This device is classified as a Bag, Reservoir (Class I — General Controls, product code BTC).

Submitted by Pedia, LLC (Fairfax, US). The FDA issued a Cleared decision on September 25, 2018, 117 days after receiving the submission on May 31, 2018.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5320.

Submission Details

510(k) Number K181424 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code BTC — Bag, Reservoir
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5320