Cleared Traditional

K961290 - IUP - TIP TRANS, IUP - PROXI TRANS

K961290 is an FDA 510(k) clearance for IUP - TIP TRANS, manufactured by Scientific Device Manufacturer, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code KXO cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K961290 · Scientific Device Manufacturer, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
194d
Days
Class 2
Risk

K961290 is an FDA 510(k) clearance for the IUP - TIP TRANS, IUP - PROXI TRANS. Classified as Monitor, Pressure, Intrauterine (product code KXO), Class II - Special Controls.

Submitted by Scientific Device Manufacturer, LLC (San Rafael, US). The FDA issued a Cleared decision on October 15, 1996 after a review of 194 days - an extended review 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: 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 Scientific Device Manufacturer, LLC devices

FDA 510(k) Submission Details - K961290

510(k) Number K961290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1996
Decision Date October 15, 1996
Days to Decision 194 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
34d slower than avg
Panel avg: 160d · This submission: 194d
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 15
Devices cleared under the same product code (KXO) and FDA review panel - the closest regulatory comparables to K961290.
EASY TRANS TIP
K982565 · Carl Schuh · Sep 1998
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