Cleared Traditional

K910227 - MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER

K910227 is an FDA 510(k) clearance for MX4043---SERIES, manufactured by Medex, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code KXO cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K910227 · Medex, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
75d
Days
Class 2
Risk

K910227 is an FDA 510(k) clearance for the MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER. Classified as Monitor, Pressure, Intrauterine (product code KXO), Class II - Special Controls.

Submitted by Medex, Inc. (Hilliard, US). The FDA issued a Cleared decision on April 3, 1991 after a review of 75 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 - K910227

510(k) Number K910227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1991
Decision Date April 03, 1991
Days to Decision 75 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
86d faster than avg
Panel avg: 161d · This submission: 75d
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 25
Devices cleared under the same product code (KXO) and FDA review panel - the closest regulatory comparables to K910227.
DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT
K920044 · Telos Medical Corp. · Apr 1992
MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER
K910742 · Graphic Controls Corp. · Jan 1992
INTRAN PLUS
K905563 · Utah Medical Products, Inc. · Jun 1991
ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.
K901084 · Healthdyne Cardiovascular, Inc. · Jun 1990
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
K910227 · MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER
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