Cleared Traditional

K161950 - Common Type Insulin Pen Needle

K161950 is the FDA 510(k) clearance for Common 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 300-day FDA review.

K161950 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
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May 2017
Decision
300d
Days
Class 2
Risk

K161950 is an FDA 510(k) clearance for the Common Type Insulin Pen Needle, 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, CN). The FDA issued a Cleared decision on May 11, 2017 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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 K161950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2016
Decision Date May 11, 2017
Days to Decision 300 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
171d slower than avg
Panel avg: 129d · This submission: 300d
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

Shenzhen Joyantech Consulting Co., Ltd.
Field Fu

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 K161950.
FAST1™ Intraosseous Infusion System
K180588 · Teleflex Medical · Apr 2018
DROPLET PEN NEEDLE
K171982 · Htl-Strefa S.A · Mar 2018
NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)
K173479 · Novo Nordisk, Inc. · Jan 2018
BD Pen Needle
K162516 · Becton, Dickinson and Company · Dec 2016
Cook Intraosseous Infusion Needles
K160887 · Cook Incorporated · Jul 2016
BD SafeAssist
K161553 · Becton, Dickinson and Company · Jul 2016