Cleared Traditional

K950708 - LIFETRACE INTRAUTERINE PRESSURE CATHETE...

K950708 is the FDA 510(k) clearance for LIFETRACE INTRAUTERINE PRESSURE CATHETE... by Graphic Controls Corp.. It is a Class 2 Obstetrics & Gynecology device (product code KXO) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K950708 · Graphic Controls Corp. · Obstetrics & Gynecology device
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May 1995
Decision
101d
Days
Class 2
Risk

K950708 is an FDA 510(k) clearance for the LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000. Classified as Monitor, Pressure, Intrauterine (product code KXO), Class II - Special Controls.

Submitted by Graphic Controls Corp. (Buffalo, US). The FDA issued a Cleared decision on May 25, 1995 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Graphic Controls Corp. devices

Submission Details

510(k) Number K950708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1995
Decision Date May 25, 1995
Days to Decision 101 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 160d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K950708.
SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)
K974730 · Graphic Controls Corp. · Jul 1998
SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)
K964279 · Graphic Controls Corp. · Jan 1997
LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER
K950498 · Graphic Controls Corp. · Jul 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