Cleared Traditional

Insulin Syringe, Insulin Syringe with Safety Retractable (K202570) - FDA 510(k) Clearance

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

K202570 · Jiangsu Micsafe Medical Technology Co., Ltd. · General Hospital
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Jul 2021
Decision
301d
Days
Class 2
Risk

K202570 is an FDA 510(k) clearance for the Insulin Syringe, Insulin Syringe with Safety Retractable. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Jiangsu Micsafe Medical Technology Co., Ltd. (Yancheng, CN). The FDA issued a Cleared decision on July 2, 2021 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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. Elevated predicate reliance profile. 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 Jiangsu Micsafe Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K202570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2020
Decision Date July 02, 2021
Days to Decision 301 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
172d slower than avg
Panel avg: 129d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEG Syringe, Antistick
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 - MEG Syringe, Antistick

All 38
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K202570.
Hypodermic Safety Needle
K211555 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Oct 2021
Sterile Syringe With Safety Needle
K211753 · Jiangxi Hongda Medical Equipment Group , Ltd. · Oct 2021
DR Safety Syringe, Sterile Hypodermic needle for Single use
K212226 · Zhuhai DR Medical Instruments Co., Ltd. · Sep 2021
TK Insulin Syringe with/without Saftey Retractable Device
K191639 · Anhui Tiankang Medical Technology Co., Ltd. · Sep 2020
1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle
K192551 · Jiangsu Caina Medical Co.,Ltd · Aug 2020
Retractable Safety Insulin Syringe
K193022 · Jiangsu Caina Medical Co.,Ltd · Jul 2020