Cleared Traditional

K262215 - Profoject™ Safety Sliding Blood Collection Set

K262215 is an FDA 510(k) clearance for Profoject Safety Sliding Blood Collecti..., 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 87-day FDA review.

K262215 · CMT Health PTE., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
87d
Days
Class 2
Risk

K262215 is an FDA 510(k) clearance for the Profoject™ Safety Sliding Blood Collection Set. 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 September 25, 2026 after a review of 87 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 CMT Health PTE., Ltd. devices

FDA 510(k) Submission Details - K262215

510(k) Number K262215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2026
Decision Date September 25, 2026
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
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 180
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