Cleared Traditional

K212499 - BD Insulin Syringe (0.3mL)

K212499 is the FDA 510(k) clearance for BD Insulin Syringe (0.3mL) by Becton, Dickinson and Company. It is a Class 2 General Hospital device (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

Submission Details

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.

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 285
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