510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K915495Substantially Equivalent

Deseret Positional Suture Wing

BD Becton Dickinson Vacutainer Systems Preanalytic, Sandy UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915495 is the FDA 510(k) clearance record for DESERET POSITIONAL SUTURE WING, a class I device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code KMK (Device, Intravascular Catheter Securement). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K915495.

Clearance record

Decision date
Received
(119 days to decision)
Product code
KMK Device, Intravascular Catheter Securement
Regulation
21 CFR 880.5210
Device class
Class I
Review panel
General Hospital
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic 9450 S. State Sreet, Sandy UT
510(k) summary
Summary
Third party review
No

Clearances, product code KMK

Trailing 12 months

FDA records hold no clearances under product code KMK in the trailing twelve months.

FDA records show no clearances under product code KMK in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMK, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260