Cleared Traditional

K261829 - Profoject™ Dual-Safety Pen Needles

K261829 is an FDA 510(k) clearance for Profoject Dual-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 57-day FDA review.

K261829 · CMT Health PTE., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
57d
Days
Class 2
Risk

K261829 is an FDA 510(k) clearance for the Profoject™ Dual-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 July 29, 2026 after a review of 57 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 - K261829

510(k) Number K261829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2026
Decision Date July 29, 2026
Days to Decision 57 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
72d faster than avg
Panel avg: 129d · This submission: 57d
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 454
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K261829.
Promisemed X-Safety Pen Needle
K261719 · Promisemed Hangzhou Meditech Co., Ltd. · Aug 2026
Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)
K262427 · Hh Global Technology, Inc. · Aug 2026
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™ Pen Needles (Model A
K260739 · CMT Health PTE., Ltd. · Jul 2026
Profoject™ Safety Pen Needles
K260855 · CMT Health PTE., Ltd. · Jun 2026
Verisafe Safety Sterile Needles (SSN)
K254273 · Promisemed Hangzhou Meditech Co., Ltd. · Apr 2026