Cleared Traditional

K220603 - Disposable Medical Safety Hypodermic Needle

K220603 is an FDA 510(k) clearance for Disposable Medical Safety Hypodermic Needle, manufactured by Hantech Medical Device Co., Ltd.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K220603 · Hantech Medical Device Co., Ltd. · General Hospital
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Aug 2022
Decision
174d
Days
Class 2
Risk

K220603 is an FDA 510(k) clearance for the Disposable Medical Safety Hypodermic Needle. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Hantech Medical Device Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on August 23, 2022 after a review of 174 days - an extended review cycle.

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 Hantech Medical Device Co., Ltd. devices

FDA 510(k) Submission Details - K220603

510(k) Number K220603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2022
Decision Date August 23, 2022
Days to Decision 174 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
45d slower than avg
Panel avg: 129d · This submission: 174d
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 271
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K220603.
Sterile Hypodermic Needles for Single Use
K221066 · Sichuan Prius Biotechnology Co., Ltd. · Oct 2022
Sterile Safety Hypodermic Needles for Single Use
K221080 · Sichuan Prius Biotechnology Co., Ltd. · Oct 2022
Promisemed X-Safety Pen Needle
K220129 · Promisemed Hangzhou Meditech Co., Ltd. · Sep 2022
SurGuard3 Safety Hypodermic Needle
K212095 · Terumo Europe N.V. · Aug 2022
Insulin Pen Needle
K221176 · Tianjin Huahong Technology Co., Ltd. · Jul 2022
BD Pen Needle
K213478 · Becton, Dickinson and Company · Jun 2022