Cleared Traditional

Sterile syringes for single use with/without needle (K211211) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 239
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