510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K854725Substantially Equivalent

Hurwitz Amniocentesis Needle

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

K854725 is the FDA 510(k) clearance record for HURWITZ AMNIOCENTESIS NEEDLE, a class I device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code HIO (Sampler, Amniotic Fluid (Amniocentesis Tray)). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K854725.

Clearance record

Decision date
Received
(115 days to decision)
Product code
HIO Sampler, Amniotic Fluid (Amniocentesis Tray)
Regulation
21 CFR 884.1550
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic Mack Centre Dr., Paramus NJ
Third party review
No

Clearances, product code HIO

Trailing 12 months

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

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