Cleared Special

K170386 - BD Ultra-Fine Insulin Syringe

K170386 is the FDA 510(k) clearance for BD Ultra-Fine Insulin Syringe by Becton, Dickinson Company. It is a Class 2 General Hospital device (product code FMF) cleared through the Special 510(k) pathway after a 63-day FDA review.

K170386 · Becton, Dickinson Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
63d
Days
Class 2
Risk

K170386 is an FDA 510(k) clearance for the BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin.... Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Becton, Dickinson Company (Franklin Lakes, US). The FDA issued a Cleared decision on April 12, 2017 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Becton, Dickinson Company devices

Submission Details

510(k) Number K170386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2017
Decision Date April 12, 2017
Days to Decision 63 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

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 286
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K170386.
Nipro Syringe
K173029 · Nipro Medical Corporation · Mar 2018
Merit Syringe
K173601 · Merit Medical Systems, Inc. · Jan 2018
Merit Syringe
K171362 · Merit Medical Systems, Inc. · Aug 2017
BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe
K162081 · Becton, Dickinson and Company · Dec 2016
BD U-500 INSULIN SYRINGE
K151870 · Becton, Dickinson and Company · Jul 2016
LITe BIO Delivery System
K160978 · Stryker Corporation · Jul 2016