Cleared Traditional

K212499 - BD Insulin Syringe (0.3mL)

K212499 is an FDA 510(k) clearance for BD Insulin Syringe (0.3mL), manufactured by Becton, Dickinson and Company. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K212499 · Becton, Dickinson and Company · General Hospital
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Mar 2022
Decision
212d
Days
Class 2
Risk

K212499 is an FDA 510(k) clearance for the BD Insulin Syringe (0.3mL). Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on March 9, 2022 after a review of 212 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 Becton, Dickinson and Company devices

FDA 510(k) Submission Details - K212499

510(k) Number K212499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2021
Decision Date March 09, 2022
Days to Decision 212 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
83d slower than avg
Panel avg: 129d · This submission: 212d
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 480
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K212499.
Verifine Safety Syringe with Fixed Needle
K213560 · Promisemed Hangzhou Meditech Co., Ltd. · Apr 2022
Qitexio
K203738 · Medex · Mar 2022
Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use
K212920 · Shandong Weigao Group Medical Polymer Co., Ltd. · Mar 2022
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