Cleared Traditional

K212207 - Sterile Hypodermic Syringe for Single Use

K212207 is an FDA 510(k) clearance for Sterile Hypodermic Syringe for Single Use, manufactured by Shandong Weigao Group Medical Polymer Co., Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 616-day FDA review.

K212207 · Shandong Weigao Group Medical Polymer Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
616d
Days
Class 2
Risk

K212207 is an FDA 510(k) clearance for the Sterile Hypodermic Syringe for Single Use. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Shandong Weigao Group Medical Polymer Co., Ltd. (Weihai, CN). The FDA issued a Cleared decision on March 23, 2023 after a review of 616 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 Shandong Weigao Group Medical Polymer Co., Ltd. devices

FDA 510(k) Submission Details - K212207

510(k) Number K212207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2021
Decision Date March 23, 2023
Days to Decision 616 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
487d slower than avg
Panel avg: 129d · This submission: 616d
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 330
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K212207.
Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use
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