Cleared Traditional

K801758 - MMI/GAELTEC CATHETER INTRAUTERINE

K801758 is an FDA 510(k) clearance for MMI/GAELTEC CATHETER INTRAUTERINE, manufactured by Medical Measurements, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code KXO cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K801758 · Medical Measurements, Inc. · Obstetrics & Gynecology device
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Aug 1980
Decision
17d
Days
Class 2
Risk

K801758 is an FDA 510(k) clearance for the MMI/GAELTEC CATHETER INTRAUTERINE. Classified as Monitor, Pressure, Intrauterine (product code KXO), Class II - Special Controls.

Submitted by Medical Measurements, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 14, 1980 after a review of 17 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 Medical Measurements, Inc. devices

FDA 510(k) Submission Details - K801758

510(k) Number K801758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1980
Decision Date August 14, 1980
Days to Decision 17 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
143d faster than avg
Panel avg: 160d · This submission: 17d
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 16
Devices cleared under the same product code (KXO) and FDA review panel - the closest regulatory comparables to K801758.
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
INTRAUTERINE CATHETER TIP
K790678 · Sonicaid, Inc. · May 1979
MODEL 8100 PRE-FILLED INTRAUTERINE
K790418 · Ge Medical Systems Information Technologies · Mar 1979