Cleared Traditional

Blood collection tube holders

K250961 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Jun 2025
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K250961 is an FDA 510(k) clearance for the Blood collection tube holders, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on June 4, 2025, 65 days after receiving the submission on March 31, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K250961 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2025
Decision Date June 04, 2025
Days to Decision 65 days
Submission Type Traditional
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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