Cleared Abbreviated

K212949 - Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K212949 · Henan Nursecare Biotechnology Co., Ltd. · General Hospital
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Feb 2022
Decision
161d
Days
Class 2
Risk

K212949 is an FDA 510(k) clearance for the Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needl.... Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Henan Nursecare Biotechnology Co., Ltd. (Xinxiang, CN). The FDA issued a Cleared decision on February 24, 2022 after a review of 161 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Henan Nursecare Biotechnology Co., Ltd. devices

Submission Details

510(k) Number K212949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2021
Decision Date February 24, 2022
Days to Decision 161 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 128d · This submission: 161d
Pathway characteristics
Standards-based clearance path.

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 Consultant

Cnmed Consultant
Johnson Liu

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 162
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