Cleared Traditional

K211211 - Sterile syringes for single use with/wi...

K211211 is an FDA 510(k) clearance for Sterile syringes for single use with/wi..., manufactured by Azur Medical Company, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K211211 · Azur Medical Company, Inc. · General Hospital
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Oct 2021
Decision
167d
Days
Class 2
Risk

K211211 is an FDA 510(k) clearance for the Sterile syringes for single use with/without needle. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Azur Medical Company, Inc. (Richmond, US). The FDA issued a Cleared decision on October 7, 2021 after a review of 167 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 Azur Medical Company, Inc. devices

FDA 510(k) Submission Details - K211211

510(k) Number K211211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2021
Decision Date October 07, 2021
Days to Decision 167 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
38d slower than avg
Panel avg: 129d · This submission: 167d
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
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K211211.
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
Sterile hypodermic syringes for single use
K211728 · Jiangsu Kangyou Medical Instrument Co., Ltd. · Oct 2021
TrueCare Biomedix Tamper Evident Cap
K210818 · Us Infusion Inc. D/B/A Truecare Biomedix-USA · Sep 2021
Sterile syringe for single use with/without needle
K210227 · Zhejiang Kangkang Medical-Devices Co., Ltd. · Sep 2021