Cleared Traditional

Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) (K202319) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202319 · Tianjin Huahong Technology Co., Ltd. · General Hospital
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Nov 2021
Decision
452d
Days
Class 2
Risk

K202319 is an FDA 510(k) clearance for the Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type). 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 November 12, 2021 after a review of 452 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Tianjin Huahong Technology Co., Ltd. devices

Submission Details

510(k) Number K202319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2020
Decision Date November 12, 2021
Days to Decision 452 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
323d slower than avg
Panel avg: 129d · This submission: 452d
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 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 K202319.
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BD Nano 2nd Gen Pen Needle
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Sterile Hypodermic Needles for Single Use
K211214 · Azur Medical Company, Inc. · Oct 2021
SteriCap Mini Needle and Standard Needles
K212805 · Ocuject, LLC · Sep 2021
Sterile Hypodermic Needles for Single Use
K210232 · Zhejiang Kangkang Medical-Devices Co., Ltd. · Sep 2021