Cleared Special

Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set

K250907 · Sol-Millennium Medical, Inc. · General Hospital
Apr 2025
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K250907 is an FDA 510(k) clearance for the Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Sol-Millennium Medical, Inc. (Chicago, US). The FDA issued a Cleared decision on April 30, 2025, 35 days after receiving the submission on March 26, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K250907 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2025
Decision Date April 30, 2025
Days to Decision 35 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1675

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