510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K870719Substantially Equivalent

Sensir System

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

K870719 is the FDA 510(k) clearance record for SENSIR SYSTEM, a class II device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code JWY (Manual Antimicrobial Susceptibility Test Systems). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K870719.

Clearance record

Decision date
Received
(115 days to decision)
Product code
JWY Manual Antimicrobial Susceptibility Test Systems
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic 1 Becton Dr., Franklin Lakes NJ
Third party review
No

Clearances, product code JWY

Trailing 12 months
2 clearances under product code JWY in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JWY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260