Cleared Traditional

Disposable Insulin Syringe (K222672) - FDA 510(k) Clearance

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

K222672 · Hantech Medical Device Co., Ltd. · General Hospital
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Mar 2023
Decision
181d
Days
Class 2
Risk

K222672 is an FDA 510(k) clearance for the Disposable Insulin Syringe. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Hantech Medical Device Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on March 6, 2023 after a review of 181 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 K222672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2022
Decision Date March 06, 2023
Days to Decision 181 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 129d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 239
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K222672.
Sol-Guard Auto-disable Syringe
K220713 · Sol-Millennium Medical, Inc. · May 2023
EpiFinder
K221974 · Omeq Medical , Ltd. · Apr 2023
Sterile Hypodermic Syringe for Single Use
K212207 · Shandong Weigao Group Medical Polymer Co., Ltd. · Mar 2023
Insulin Syringe
K223453 · Promisemed Hangzhou Meditech Co., Ltd. · Mar 2023
CompuFlo Epidural Computer Controlled Anesthesia System
K221702 · Milestone Scientific, Inc. · Feb 2023
Sofjec
K212635 · Hwajin Medical Co., Ltd. · Feb 2023