Cleared Traditional

K790678 - INTRAUTERINE CATHETER TIP

K790678 is an FDA 510(k) clearance for INTRAUTERINE CATHETER TIP, manufactured by Sonicaid, Inc.. The device is a Class 2 Radiology device with product code KXO cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K790678 · Sonicaid, Inc. · Radiology device
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May 1979
Decision
32d
Days
Class 2
Risk

K790678 is an FDA 510(k) clearance for the INTRAUTERINE CATHETER TIP. Classified as Monitor, Pressure, Intrauterine (product code KXO), Class II - Special Controls.

Submitted by Sonicaid, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 11, 1979 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2700 - the FDA radiology and imaging software oversight 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 Sonicaid, Inc. devices

FDA 510(k) Submission Details - K790678

510(k) Number K790678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1979
Decision Date May 11, 1979
Days to Decision 32 days
Submission Type Traditional
Review Panel Radiology (RA)
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: 107d · This submission: 32d
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 Radiology 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 K790678.
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
MODEL 8100 PRE-FILLED INTRAUTERINE
K790418 · Ge Medical Systems Information Technologies · Mar 1979