Cleared Traditional

K210065 - Verifine Safety Type Insulin Pen Needle

K210065 is the FDA 510(k) clearance for Verifine Safety Type Insulin Pen Needle by Promisemed Hangzhou Meditech Co., Ltd.. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K210065 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
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Apr 2021
Decision
101d
Days
Class 2
Risk

K210065 is an FDA 510(k) clearance for the Verifine Safety Type Insulin Pen Needle. 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 April 22, 2021 after a review of 101 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Promisemed Hangzhou Meditech Co., Ltd. devices

Submission Details

510(k) Number K210065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2021
Decision Date April 22, 2021
Days to Decision 101 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
28d faster than avg
Panel avg: 129d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Vee Care (Asia) Limited
Wei Shan Hsu

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 K210065.
Promisemed Insulin Pen Needle
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Safety Winged Blood Collection Sets
K211293 · Promisemed Hangzhou Meditech Co., Ltd. · Jun 2021
NovoFine
K210258 · Novo Nordisk, Inc. · Jun 2021
EZ-IO Intraosseous Vascular Access System
K202492 · Teleflex Medical · Mar 2021
Easydrip Pen Needle, Easydrip Plus Pen Needle
K193422 · Sandstone Medical (Suzhou), Inc. · Feb 2021
Promisemed Covered Safety Pen Needle
K202681 · Promisemed Hangzhou Meditech Co., Ltd. · Dec 2020