Cleared Special

K010890 - BD ULTRA-FINE II INSULIN SYRINGE-MINI N...

K010890 is the FDA 510(k) clearance for BD ULTRA-FINE II INSULIN SYRINGE-MINI N... by Becton, Dickinson and Co.. It is a Class 2 General Hospital device (product code FMF) cleared through the Special 510(k) pathway after a 24-day FDA review.

K010890 · Becton, Dickinson and Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
24d
Days
Class 2
Risk

K010890 is an FDA 510(k) clearance for the BD ULTRA-FINE II INSULIN SYRINGE-MINI NEEDLE, MODEL 30G * 3/16 (5MM). Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Becton, Dickinson and Co. (Franklin Lakes, US). The FDA issued a Cleared decision on April 19, 2001 after a review of 24 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 and Co. devices

Submission Details

510(k) Number K010890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2001
Decision Date April 19, 2001
Days to Decision 24 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
105d faster than avg
Panel avg: 129d · This submission: 24d
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 K010890.
DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
K020666 · Baxter Healthcare Corp · Jun 2002
DUPLOREACH
K014088 · Baxter Healthcare Corp · Jun 2002
APPLICATOR TIP/DUAL SPRAYER KIT
K010708 · Interpore Cross Intl. · Apr 2001
SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE
K003571 · Terumo Medical Corp. · Feb 2001
STERILE PISTON SYRINGE
K002717 · Abbott Laboratories · Jan 2001
DUPLOGRIP
K003193 · Baxter Healthcare Corp · Nov 2000