Cleared Traditional

K203359 - BD Flu+ Syringe

K203359 is the FDA 510(k) clearance for BD Flu+ Syringe 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 254-day FDA review.

K203359 · Becton, Dickinson and Company · General Hospital
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Jul 2021
Decision
254d
Days
Class 2
Risk

K203359 is an FDA 510(k) clearance for the BD Flu+ Syringe. 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 July 28, 2021 after a review of 254 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 K203359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2020
Decision Date July 28, 2021
Days to Decision 254 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
125d slower than avg
Panel avg: 129d · This submission: 254d
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 K203359.
PreferX Delivery System
K210997 · Md3, LLC · Sep 2021
Disposable Sterile Syringe, Disposable Sterile Syringe with Needle
K210991 · Guangdong Antmed Co., Ltd. · Aug 2021
Auto Disable Syringe
K210464 · Anhui Tiankang Medical Technology Co., Ltd. · Aug 2021
SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX
K210103 · Lifelong Meditech Private Limited · Jul 2021
1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock
K210200 · Set Medikal Sanayi VE Ticaret Anonim Sirketi · May 2021
MicroDose Injector
K203264 · Medone Surgical, Inc. · Apr 2021