Cleared Traditional

K991235 - SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)

K991235 is an FDA 510(k) clearance for SOFTRANS TEMP INTRAUTERINE PRESSURE CAT..., manufactured by Ludlow Technical Products. The device is a Class 2 Obstetrics & Gynecology device with product code KXO cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K991235 · Ludlow Technical Products · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
87d
Days
Class 2
Risk

K991235 is an FDA 510(k) clearance for the SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP .... Classified as Monitor, Pressure, Intrauterine (product code KXO), Class II - Special Controls.

Submitted by Ludlow Technical Products (Chicopee, US). The FDA issued a Cleared decision on July 8, 1999 after a review of 87 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 Ludlow Technical Products devices

FDA 510(k) Submission Details - K991235

510(k) Number K991235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1999
Decision Date July 08, 1999
Days to Decision 87 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 160d · This submission: 87d
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 13
Devices cleared under the same product code (KXO) and FDA review panel - the closest regulatory comparables to K991235.
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
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