Cleared Traditional

K920044 - DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT

K920044 is an FDA 510(k) clearance for DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT, manufactured by Telos Medical Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code KXO cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K920044 · Telos Medical Corp. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Apr 1992
Decision
88d
Days
Class 2
Risk

K920044 is an FDA 510(k) clearance for the DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT. Classified as Monitor, Pressure, Intrauterine (product code KXO), Class II - Special Controls.

Submitted by Telos Medical Corp. (Keene, US). The FDA issued a Cleared decision on April 3, 1992 after a review of 88 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 Telos Medical Corp. devices

FDA 510(k) Submission Details - K920044

510(k) Number K920044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1992
Decision Date April 03, 1992
Days to Decision 88 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 160d · This submission: 88d
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 16
Devices cleared under the same product code (KXO) and FDA review panel - the closest regulatory comparables to K920044.
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
MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER
K910227 · Medex, Inc. · Apr 1991