510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K935483Substantially Equivalent

E-Z Prep(r) Tray with Hibiclens(r)

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

K935483 is the FDA 510(k) clearance record for E-Z PREP(R) TRAY WITH HIBICLENS(R), a class II device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code LRO (General Surgery Tray). FDA's definition for product code LRO reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the...". FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K935483.

Clearance record

Decision date
Received
(86 days to decision)
Product code
LRO General Surgery Tray
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic One Becton Dr., Franklin Lake NJ
510(k) summary
Summary
Third party review
No

Clearances, product code LRO

Trailing 12 months

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

FDA records show no clearances under product code LRO in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LRO, 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