Cleared Special

K170386 - BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle

K170386 is an FDA 510(k) clearance for BD Ultra-Fine Insulin Syringe, manufactured by Becton, Dickinson Company. The device is a Class 2 General Hospital device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K170386

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
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
Modification to existing cleared device.

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 755
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K170386.
Merit Syringe
K171362 · Merit Medical Systems, Inc. · Aug 2017
Graftgun Universal Graft Delivery System
K170675 · SurGenTec, LLC · Jul 2017
CompuFlo Epidural Computer Controlled Anesthesia System
K161883 · Milestone Scientific, Inc. · Jun 2017
Freedom Syringe
K161812 · Procedure Products, Inc. · Mar 2017
Sterile Single-use Syringe with Needle
K163161 · Jiangxi Hongda Medical Equipment Group , Ltd. · Mar 2017
Vesco Medical NRFit Tip Syringes
K170218 · Vesco Medical, LLC · Feb 2017
K170386 · BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle
Download PDF FDA Summary Becton, Dickinson Com…