Cleared Special

K261719 - Promisemed X-Safety Pen Needle

K261719 is an FDA 510(k) clearance for Promisemed X-Safety Pen Needle, manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The device is a Class 2 General Hospital device with product code FMI cleared through the Special 510(k) pathway after a 91-day FDA review.

K261719 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
91d
Days
Class 2
Risk

K261719 is an FDA 510(k) clearance for the Promisemed X-Safety Pen Needle. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on August 25, 2026 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Promisemed Hangzhou Meditech Co., Ltd. devices

FDA 510(k) Submission Details - K261719

510(k) Number K261719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2026
Decision Date August 25, 2026
Days to Decision 91 days
Submission Type Special
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
38d faster than avg
Panel avg: 129d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

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 K261719.
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™ Dual-Safety Pen Needles
K261829 · CMT Health PTE., Ltd. · Jul 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