Cleared Traditional

Disposable Medical Safety Hypodermic Needle (K220603) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 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