Cleared Traditional

K901084 - ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.

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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Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 161d · 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 20
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
AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED
K896122 · Spectramed, Inc. · Jan 1990
ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING
K895763 · Healthdyne Cardiovascular, Inc. · Dec 1989
MODEL DT-BAL, BALANCE SAVER
K895323 · Spectramed, Inc. · Oct 1989
K901084 · ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.
Download PDF Healthdyne Cardiovasc…