Cleared Traditional

K211210 - Sterile Auto-Disable Syringes with/with...

K211210 is an FDA 510(k) clearance for Sterile Auto-Disable Syringes with/with..., 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 279-day FDA review.

K211210 · Azur Medical Company, Inc. · General Hospital
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Jan 2022
Decision
279d
Days
Class 2
Risk

K211210 is an FDA 510(k) clearance for the Sterile Auto-Disable Syringes with/without Needle for Single Use. 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 January 27, 2022 after a review of 279 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 - K211210

510(k) Number K211210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2021
Decision Date January 27, 2022
Days to Decision 279 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
150d slower than avg
Panel avg: 129d · This submission: 279d
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 K211210.
BD Insulin Syringe (0.3mL)
K212499 · Becton, Dickinson and Company · Mar 2022
Sure-Fine Insulin Syringes
K210848 · Shina Med Corporation · Mar 2022
Instylla Delivery Kit
K213632 · Instylla, Inc. · Feb 2022
Disposable Syringe with Needle
K211482 · Shandong Qinkai Medical Industry Co., Ltd. · 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