Cleared Traditional

Safety Insulin Syringes (K220061) - FDA 510(k) Clearance

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

K220061 · Berpu Medical Technology Co., Ltd. · General Hospital
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Aug 2022
Decision
225d
Days
Class 2
Risk

K220061 is an FDA 510(k) clearance for the Safety Insulin Syringes. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Berpu Medical Technology Co., Ltd. (Wenzhou, CN). The FDA issued a Cleared decision on August 23, 2022 after a review of 225 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 Berpu Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K220061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2022
Decision Date August 23, 2022
Days to Decision 225 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
96d slower than avg
Panel avg: 129d · This submission: 225d
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 K220061.
Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle
K221247 · Jiangsu Kangbao Medical Equipment Co., Ltd. · Nov 2022
Disposable Sterile Syringe with permanently attached needle
K220057 · Shinva Ande Healthcare Apparatus Co., Ltd. · Oct 2022
Sterile Hypodermic Syringes for Single Use with Safety Needles
K221073 · Sichuan Prius Biotechnology Co., Ltd. · Oct 2022
Jeesung Safety Syringe and Single Use Needles
K212518 · Jeesung Medical Co., Ltd. · Aug 2022
Automatically Retractable Safety Syringe
K213077 · Zhejiang Lingyang Medical Apparatus Co., Ltd. · Apr 2022
Disposable Automatically Retractable Insulin Safety Syringe
K210216 · Shantou Wealy Medical Instrument Co.,Ltd · Mar 2022