Cleared Traditional

Disposable Syringe with Needle (K211482) - FDA 510(k) Clearance

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

K211482 · Shandong Qinkai Medical Industry Co., Ltd. · General Hospital
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Jan 2022
Decision
257d
Days
Class 2
Risk

K211482 is an FDA 510(k) clearance for the Disposable Syringe with Needle. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Shandong Qinkai Medical Industry Co., Ltd. (Heze City, CN). The FDA issued a Cleared decision on January 24, 2022 after a review of 257 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 Shandong Qinkai Medical Industry Co., Ltd. devices

Submission Details

510(k) Number K211482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2021
Decision Date January 24, 2022
Days to Decision 257 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
128d slower than avg
Panel avg: 129d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 243
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K211482.
Sure-Fine Insulin Syringes
K210848 · Shina Med Corporation · Mar 2022
Instylla Delivery Kit
K213632 · Instylla, Inc. · Feb 2022
Sterile Auto-Disable Syringes with/without Needle for Single Use
K211210 · Azur Medical Company, Inc. · Jan 2022
CHIRANA Insulin Syringes
K201044 · Chirana T. Injecta · Jan 2022
Sterile Syringe for Single Use
K210914 · Jiangsu Suyun Medical Material Co., Ltd. · Dec 2021
MiniLoad Syringe
K212544 · Ocuject, LLC · Oct 2021