Cleared Traditional

K901084 - ISOFLO INTRAUTERINE PRESSURE MONITORING...

K901084 is an FDA 510(k) clearance for ISOFLO INTRAUTERINE PRESSURE MONITORING..., manufactured by Healthdyne Cardiovascular, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code KXO cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K901084 · Healthdyne Cardiovascular, Inc. · Obstetrics & Gynecology device
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Jun 1990
Decision
86d
Days
Class 2
Risk

K901084 is an FDA 510(k) clearance for the ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.. Classified as Monitor, Pressure, Intrauterine (product code KXO), Class II - Special Controls.

Submitted by Healthdyne Cardiovascular, Inc. (Irvine, US). The FDA issued a Cleared decision on June 1, 1990 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2700 - 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 Healthdyne Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K901084

510(k) Number K901084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1990
Decision Date June 01, 1990
Days to Decision 86 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
74d faster than avg
Panel avg: 160d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXO Device Classification - Class 2, Special Controls

Product Code KXO Monitor, Pressure, Intrauterine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - KXO Monitor, Pressure, Intrauterine

All 12
Devices cleared under the same product code (KXO) and FDA review panel - the closest regulatory comparables to K901084.
MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER
K910742 · Graphic Controls Corp. · Jan 1992
INTRAN PLUS
K905563 · Utah Medical Products, Inc. · Jun 1991
MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER
K910227 · Medex, Inc. · Apr 1991
DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A
K885316 · Hewlett-Packard Co. · Mar 1989
IUC - INTRAUTERINE CATHETER
K862873 · Utah Medical Products, Inc. · Feb 1987
MX4040 INTRAUTERINE PRESSURE MONITORING KIT
K860101 · Medex, Inc. · Apr 1986