510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K854986Substantially Equivalent

Bbl Port-a-Cul Aerobic Transport Sys, Modified Stu

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

K854986 is the FDA 510(k) clearance record for BBL PORT-A-CUL AEROBIC TRANSPORT SYS, MODIFIED STU, a class I device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code JSM (Culture Media, Non-Propagating Transport). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K854986.

Clearance record

Decision date
Received
(22 days to decision)
Product code
JSM Culture Media, Non-Propagating Transport
Regulation
21 CFR 866.2390
Device class
Class I
Review panel
Microbiology
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic Mack Centre Dr., Paramus NJ
Third party review
No

Clearances, product code JSM

Trailing 12 months
1 clearance under product code JSM in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JSM, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260