Cleared Traditional

K203453 - BD Hypodermic Syringe

K203453 is the FDA 510(k) clearance for BD Hypodermic 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 63-day FDA review.

K203453 · Becton, Dickinson and Company · General Hospital
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Jan 2021
Decision
63d
Days
Class 2
Risk

K203453 is an FDA 510(k) clearance for the BD Hypodermic 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 January 25, 2021 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Becton, Dickinson and Company devices

Submission Details

510(k) Number K203453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2020
Decision Date January 25, 2021
Days to Decision 63 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
66d faster than avg
Panel avg: 129d · This submission: 63d
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 K203453.
1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock
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K193273 · Promisemed Hangzhou Meditech Co., Ltd. · Jan 2021