Cleared Traditional

K220061 - Safety Insulin Syringes

K220061 is an FDA 510(k) clearance for Safety Insulin Syringes, manufactured by Berpu Medical Technology Co., Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K220061 · Berpu Medical Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K220061

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.

MEG Device Classification - Class 2, Special Controls

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 41
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