Cleared Traditional

K251352 - Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features) (FDA 510(k) Clearance)

Also includes:

Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)

K251352 · Codonics.Incorporated · Anesthesiology device

Jul 2025

Decision

72d

Days

Class 2

Risk

K251352 is an FDA 510(k) clearance for the Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features). This device is classified as a Gas-machine, Anesthesia (Class II - Special Controls, product code BSZ).

Submitted by Codonics.Incorporated (Middleburg Heights, US). The FDA issued a Cleared decision on July 11, 2025, 72 days after receiving the submission on April 30, 2025.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number	K251352 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 30, 2025
Decision Date	July 11, 2025
Days to Decision	72 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF