510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801343Substantially Equivalent

B-D Filter Needle

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

K801343 is the FDA 510(k) clearance record for B-D FILTER NEEDLE, a class II device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code FPB (Filter, Infusion Line). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K801343.

Clearance record

Decision date
Received
(15 days to decision)
Product code
FPB Filter, Infusion Line
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FPB

Trailing 12 months
1 clearance under product code FPB in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FPB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260