Cleared Traditional

K210229 - Sterile Auto-Disable Syringes with/without Needle for Single Use (FDA 510(k) Clearance)

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

K210229 · Zhejiang Kangkang Medical-Devices Co., Ltd. · General Hospital
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Feb 2022
Decision
383d
Days
Class 2
Risk

K210229 is an FDA 510(k) clearance for the Sterile Auto-Disable Syringes with/without Needle for Single Use. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Zhejiang Kangkang Medical-Devices Co., Ltd. (Yuhuan, CN). The FDA issued a Cleared decision on February 15, 2022 after a review of 383 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 Zhejiang Kangkang Medical-Devices Co., Ltd. devices

Submission Details

510(k) Number K210229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2021
Decision Date February 15, 2022
Days to Decision 383 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
255d slower than avg
Panel avg: 128d · This submission: 383d
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 162
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