Cleared Traditional

K231531 - Pediarity™ (FDA 510(k) Clearance)

K231531 · Hinlab, Inc. · Anesthesiology device

Dec 2023

Decision

209d

Days

Class 2

Risk

K231531 is an FDA 510(k) clearance for the Pediarity™. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Hinlab, Inc. (Lewes, US). The FDA issued a Cleared decision on December 21, 2023, 209 days after receiving the submission on May 26, 2023.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number	K231531 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 26, 2023
Decision Date	December 21, 2023
Days to Decision	209 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF