Cleared Traditional

K221247 - Sterile Disposable Syringe with Safety ...

K221247 is an FDA 510(k) clearance for Sterile Disposable Syringe with Safety ..., manufactured by Jiangsu Kangbao Medical Equipment Co., Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K221247 · Jiangsu Kangbao Medical Equipment Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2022
Decision
183d
Days
Class 2
Risk

K221247 is an FDA 510(k) clearance for the Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe wit.... Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Jiangsu Kangbao Medical Equipment Co., Ltd. (Yangzhou, CN). The FDA issued a Cleared decision on November 1, 2022 after a review of 183 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 Jiangsu Kangbao Medical Equipment Co., Ltd. devices

FDA 510(k) Submission Details - K221247

510(k) Number K221247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2022
Decision Date November 01, 2022
Days to Decision 183 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
54d slower than avg
Panel avg: 129d · This submission: 183d
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 Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MEG Syringe, Antistick

All 41
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K221247.
PowerPAK Syringe
K220114 · Vault Paragon Group, Inc. · Jan 2023
SafeR Syringe and SafeR Sting
K221981 · Roncadelle Operations Srl · Dec 2022
Disposable Automatically Retractable Safety Syringes (with detachable needle)
K222452 · Shantou Wealy Medical Instrument 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
Safety Insulin Syringes
K220061 · Berpu Medical Technology Co., Ltd. · Aug 2022