Cleared Traditional

K901643 - ISOFLO(TM) AMNIOCENTESIS TRAY

K901643 is an FDA 510(k) clearance for ISOFLO(TM) AMNIOCENTESIS TRAY, manufactured by Healthdyne Cardiovascular, Inc.. The device is a Class 1 Obstetrics & Gynecology device with product code HIO cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K901643 · Healthdyne Cardiovascular, Inc. · Obstetrics & Gynecology device
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Jul 1990
Decision
107d
Days
Class 1
Risk

K901643 is an FDA 510(k) clearance for the ISOFLO(TM) AMNIOCENTESIS TRAY. Classified as Sampler, Amniotic Fluid (amniocentesis Tray) (product code HIO), Class I - General Controls.

Submitted by Healthdyne Cardiovascular, Inc. (Irvine, US). The FDA issued a Cleared decision on July 25, 1990 after a review of 107 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 Healthdyne Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K901643

510(k) Number K901643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1990
Decision Date July 25, 1990
Days to Decision 107 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 160d · This submission: 107d
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 11
Devices cleared under the same product code (HIO) and FDA review panel - the closest regulatory comparables to K901643.
AMNIOTEST(TM)
K914419 · Pro-Lab, Inc. · Sep 1993
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
AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY)
K896031 · Concord/Portex · Jan 1990
PHARMASEAL GENETIC AMNIOCENTESIS TRAY
K894031 · Baxter Healthcare Corp · Aug 1989