Cleared Traditional

K964279 - SOFTRANS INTRAUTERINE PRESSURE CATHETER...

K964279 is an FDA 510(k) clearance for SOFTRANS INTRAUTERINE PRESSURE CATHETER..., manufactured by Graphic Controls Corp.. 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.

K964279 · Graphic Controls Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
86d
Days
Class 2
Risk

K964279 is an FDA 510(k) clearance for the SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC). Classified as Monitor, Pressure, Intrauterine (product code KXO), Class II - Special Controls.

Submitted by Graphic Controls Corp. (Buafflo, US). The FDA issued a Cleared decision on January 22, 1997 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 Graphic Controls Corp. devices

FDA 510(k) Submission Details - K964279

510(k) Number K964279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1996
Decision Date January 22, 1997
Days to Decision 86 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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 11
Devices cleared under the same product code (KXO) and FDA review panel - the closest regulatory comparables to K964279.
SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)
K974730 · Graphic Controls Corp. · Jul 1998
LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER
K950498 · Graphic Controls Corp. · Jul 1995
LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000
K950708 · Graphic Controls Corp. · May 1995
MX4042/MC4044 SERIES SIMULCATH(TM)
K922323 · Medex, Inc. · Jun 1994
MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER
K910742 · Graphic Controls Corp. · Jan 1992
INTRAN PLUS
K905563 · Utah Medical Products, Inc. · Jun 1991