Cleared Traditional

K202319 - Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)

K202319 is an FDA 510(k) clearance for Insulin Pen Needle (Ordinary Type), manufactured by Tianjin Huahong Technology Co., Ltd.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 452-day FDA review.

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

FDA 510(k) Submission Details - K202319

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.

FMI Device Classification - Class 2, Special Controls

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 532
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K202319.
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