510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K170386Substantially Equivalent

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

Becton Dickinson & Co, Franklin Lakes NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170386 is the FDA 510(k) clearance record for 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, a class II device, cleared for Becton Dickinson & Company on under FDA product code FMF (Syringe, Piston). FDA records list 345 510(k) clearances for Becton Dickinson & Company, from to . As of , FDA records show no recalls naming K170386.

Clearance record

Decision date
Received
(63 days to decision)
Product code
FMF Syringe, Piston
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Becton Dickinson & Company 1 Becton Dr., Franklin Lakes NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FMF

Trailing 12 months
14 clearances under product code FMF in the twelve months to October 2026, December 2025 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FMF, trailing twelve months
MonthClearances
November 20251
December 20254
January 20260
February 20261
March 20260
April 20261
May 20261
June 20262
July 20261
August 20263
September 20260
October 20260