Cleared Traditional

K260855 - Profoject™ Safety Pen Needles

K260855 is an FDA 510(k) clearance for Profoject Safety Pen Needles, manufactured by CMT Health PTE., Ltd.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K260855 · CMT Health PTE., Ltd. · General Hospital
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Jun 2026
Decision
86d
Days
Class 2
Risk

K260855 is an FDA 510(k) clearance for the Profoject™ Safety Pen Needles. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by CMT Health PTE., Ltd. (Singapore, SG). The FDA issued a Cleared decision on June 10, 2026 after a review of 86 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 - K260855

510(k) Number K260855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2026
Decision Date June 10, 2026
Days to Decision 86 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
43d faster than avg
Panel avg: 129d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 534
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K260855.
Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)
K260933 · Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · Aug 2026
Profoject™ Dual-Safety Pen Needles
K261829 · CMT Health PTE., Ltd. · Jul 2026
Profoject™ Pen Needles (Model A
K260739 · CMT Health PTE., Ltd. · Jul 2026
Verisafe Safety Sterile Needles (SSN)
K254273 · Promisemed Hangzhou Meditech Co., Ltd. · Apr 2026
Easydrip Classic Pen Needle
K252908 · Sandstone Medical (Suzhou), Inc. · Mar 2026
PRESSONE™
K253047 · Nipro Medical Corporation · Mar 2026