Cleared Traditional

K250961 - Blood collection tube holders (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250961 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
65d
Days
Class 2
Risk

K250961 is an FDA 510(k) clearance for the Blood collection tube holders. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on June 4, 2025 after a review of 65 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 862.1675 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Promisemed Hangzhou Meditech Co., Ltd. devices

Submission Details

510(k) Number K250961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 128d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 235
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K250961.
BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes
K260128 · Becton, Dickinson and Company · Apr 2026
BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube
K252378 · Becton, Dickinson and Company · Apr 2026
BD Vacutainer® Safety-Lok™ Blood Collection Set
K252506 · Becton, Dickinson and Company · Apr 2026
BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes
K252040 · Becton, Dickinson and Company · Mar 2026
Steripath® Flow™ Blood Collection System
K251812 · Magnolia Medical Technologies · Sep 2025
BD Vacutainer® Eclipse™ Blood Collection Needle
K243207 · Becton, Dickinson and Company · Jul 2025