Cleared Traditional

K212857 - Sterile Syringe for Single Use (with Ne...

K212857 is an FDA 510(k) clearance for Sterile Syringe for Single Use (with Ne..., manufactured by Jiangsu Zhiyu Medical Instrument Co, Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 608-day FDA review.

K212857 · Jiangsu Zhiyu Medical Instrument Co, Ltd. · General Hospital
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May 2023
Decision
608d
Days
Class 2
Risk

K212857 is an FDA 510(k) clearance for the Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for S.... Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Jiangsu Zhiyu Medical Instrument Co, Ltd. (Taixing, CN). The FDA issued a Cleared decision on May 9, 2023 after a review of 608 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Jiangsu Zhiyu Medical Instrument Co, Ltd. devices

FDA 510(k) Submission Details - K212857

510(k) Number K212857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2021
Decision Date May 09, 2023
Days to Decision 608 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
479d slower than avg
Panel avg: 129d · This submission: 608d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
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 - FMF Syringe, Piston

All 329
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