Cleared Special

VitaloJAK Clinic (Model 7100)

K253293 · Vitalograph , Ltd. · Anesthesiology
Dec 2025
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K253293 is an FDA 510(k) clearance for the VitaloJAK Clinic (Model 7100), a Recorder, Magnetic Tape, Medical (Class II — Special Controls, product code DSH), submitted by Vitalograph , Ltd. (Ennis Co. Clare, IE). The FDA issued a Cleared decision on December 3, 2025, 65 days after receiving the submission on September 29, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K253293 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2025
Decision Date December 03, 2025
Days to Decision 65 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DSH — Recorder, Magnetic Tape, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2800