Cleared Special

Insulin Pen Needle (K221176) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K221176 · Tianjin Huahong Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
67d
Days
Class 2
Risk

K221176 is an FDA 510(k) clearance for the Insulin Pen Needle. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Tianjin Huahong Technology Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on July 1, 2022 after a review of 67 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 Tianjin Huahong Technology Co., Ltd. devices

Submission Details

510(k) Number K221176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2022
Decision Date July 01, 2022
Days to Decision 67 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
62d faster than avg
Panel avg: 129d · This submission: 67d
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 Peers - FMI Needle, Hypodermic, Single Lumen

All 196
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K221176.
Promisemed X-Safety Pen Needle
K220129 · Promisemed Hangzhou Meditech Co., Ltd. · Sep 2022
Disposable Medical Safety Hypodermic Needle
K220603 · Hantech Medical Device Co., Ltd. · Aug 2022
SurGuard3 Safety Hypodermic Needle
K212095 · Terumo Europe N.V. · Aug 2022
BD Pen Needle
K213478 · Becton, Dickinson and Company · Jun 2022
MEDOJECT fine Pen Needles
K220614 · Chirana T. Injecta · Jun 2022
Well-life TM Pen Needles, Well-life TM Safety Pen Needles
K210748 · W. L. Med Co., Ltd. · May 2022