Cleared Traditional

K896031 - AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY)

K896031 is an FDA 510(k) clearance for AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY), manufactured by Concord/Portex. The device is a Class 1 Obstetrics & Gynecology device with product code HIO cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K896031 · Concord/Portex · Obstetrics & Gynecology device
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Jan 1990
Decision
88d
Days
Class 1
Risk

K896031 is an FDA 510(k) clearance for the AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY). Classified as Sampler, Amniotic Fluid (amniocentesis Tray) (product code HIO), Class I - General Controls.

Submitted by Concord/Portex (Keene, US). The FDA issued a Cleared decision on January 12, 1990 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Concord/Portex devices

FDA 510(k) Submission Details - K896031

510(k) Number K896031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1989
Decision Date January 12, 1990
Days to Decision 88 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
72d faster than avg
Panel avg: 160d · This submission: 88d
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 K896031.
SONO-VU US(TM), MODIFICATION
K921738 · E-Z-Em, Inc. · Apr 1992
SONO-VU US(TM)
K904583 · E-Z-Em, Inc. · Jun 1991
PERCU-SET(TM)
K900021 · E-Z-Em, Inc. · Mar 1990
PHARMASEAL GENETIC AMNIOCENTESIS TRAY
K894031 · Baxter Healthcare Corp · Aug 1989
ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE
K892846 · Cook Ob/Gyn · Jul 1989
HURWITZ AMNIOCENTESIS NEEDLE
K854725 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1986