Cleared Traditional

K211482 - Disposable Syringe with Needle

K211482 is an FDA 510(k) clearance for Disposable Syringe with Needle, manufactured by Shandong Qinkai Medical Industry Co., Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K211482 · Shandong Qinkai Medical Industry Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K211482

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.

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 590
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
K211482 · Disposable Syringe with Needle
Download PDF FDA Summary Shandong Qinkai Medic…