Cleared Traditional

K262242 - Profoject™ Safe Push Button Blood Collection Sets

K262242 is an FDA 510(k) clearance for Profoject Safe Push Button Blood Collec..., manufactured by CMT Health PTE., Ltd.. The device is a Class 2 General Hospital device with product code JKA cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K262242 · CMT Health PTE., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
119d
Days
Class 2
Risk

K262242 is an FDA 510(k) clearance for the Profoject™ Safe Push Button Blood Collection Sets. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by CMT Health PTE., Ltd. (Singapore, SG). The FDA issued a Cleared decision on October 28, 2026 after a review of 119 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K262242

510(k) Number K262242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2026
Decision Date October 28, 2026
Days to Decision 119 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
10d faster than avg
Panel avg: 129d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

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 237
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K262242.
Sol-Guard™ Safety Pull Button Collection Set
K260857 · Sol-Millennium Medical, Inc. · Oct 2026
BD Vacutainer® Serum Blood Collection Tubes
K252344 · Becton, Dickinson and Company · Oct 2026
Profoject™ Safety Sliding Blood Collection Set
K262215 · CMT Health PTE., Ltd. · Sep 2026
Female Culture Device
K252899 · Zhejiang Kindly Medical Device Co., Ltd. · Jun 2026
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
K262242 · Profoject™ Safe Push Button Blood Collection Sets
Download PDF FDA Summary CMT Health PTE., Ltd.