Cleared Traditional

K854725 - HURWITZ AMNIOCENTESIS NEEDLE

K854725 is an FDA 510(k) clearance for HURWITZ AMNIOCENTESIS NEEDLE, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 Obstetrics & Gynecology device with product code HIO cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K854725 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Mar 1986
Decision
115d
Days
Class 1
Risk

K854725 is an FDA 510(k) clearance for the HURWITZ AMNIOCENTESIS NEEDLE. Classified as Sampler, Amniotic Fluid (amniocentesis Tray) (product code HIO), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on March 17, 1986 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1550 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K854725

510(k) Number K854725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1985
Decision Date March 17, 1986
Days to Decision 115 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 160d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

HIO Device Classification - Class 1, General Controls

Product Code HIO Sampler, Amniotic Fluid (amniocentesis Tray)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.1550
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HIO Sampler, Amniotic Fluid (amniocentesis Tray)

All 13
Devices cleared under the same product code (HIO) and FDA review panel - the closest regulatory comparables to K854725.
AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY)
K896031 · Concord/Portex · Jan 1990
PHARMASEAL GENETIC AMNIOCENTESIS TRAY
K894031 · Baxter Healthcare Corp · Aug 1989
ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE
K892846 · Cook Ob/Gyn · Jul 1989
PMS AMNIOCENTESIS TRAY/KIT
K850632 · Professional Medical Services · May 1985
UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE
K844558 · Universal Medical Instrument Corp. · Jan 1985
AMNIO CENTESES KIT W/NEEDLE
K830019 · Universal Medical Instrument Corp. · Jan 1983