Cleared Special

K242632 - Verifine Pen Needles

K242632 is the FDA 510(k) clearance for Verifine Pen Needles by Promisemed Hangzhou Meditech Co., Ltd.. It is a Class 2 General Hospital device (product code FMI) cleared through the Special 510(k) pathway after a 23-day FDA review.

K242632 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
23d
Days
Class 2
Risk

K242632 is an FDA 510(k) clearance for the Verifine® Pen Needles. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on September 26, 2024 after a review of 23 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. 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. Low regulatory complexity profile. 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

Submission Details

510(k) Number K242632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2024
Decision Date September 26, 2024
Days to Decision 23 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
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Consultant

Medtech Review, LLC
John Beasley

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 235
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K242632.
SureFine Pen Needle
K250658 · Shina Med Corporation · Apr 2025
Safety Winged Blood Collection Sets
K243806 · Promisemed Hangzhou Meditech Co., Ltd. · Jan 2025
ACE Cannula
K242741 · Ace Medical Industry Co., Ltd. · Jan 2025
ZIEN IO Intraosseous Access System
K240915 · Zien Medical Technologies, Inc. · Jul 2024
Sterile Safety Hypodermic Needles for Single Use
K232165 · Berpu Medical Technology Co., Ltd. · Feb 2024
Sterile Hypodermic Needles for Single Use
K233037 · Zhejiang Kindly Medical Device Co., Ltd. · Dec 2023