Cleared Traditional

K883832 - CATHETER, INTRAUTERINE AND INTRODUCER

K883832 is an FDA 510(k) clearance for CATHETER, 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 95-day FDA review.

K883832 · Telos Medical Corp. · Obstetrics & Gynecology device
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Dec 1988
Decision
95d
Days
Class 2
Risk

K883832 is an FDA 510(k) clearance for the CATHETER, INTRAUTERINE AND INTRODUCER. 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 December 13, 1988 after a review of 95 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 Telos Medical Corp. devices

FDA 510(k) Submission Details - K883832

510(k) Number K883832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1988
Decision Date December 13, 1988
Days to Decision 95 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 160d · This submission: 95d
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 K883832.
INTRAN PLUS
K905563 · Utah Medical Products, Inc. · Jun 1991
MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER
K910227 · Medex, Inc. · Apr 1991
DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A
K885316 · Hewlett-Packard Co. · Mar 1989
IUC - INTRAUTERINE CATHETER
K862873 · Utah Medical Products, Inc. · Feb 1987
MX4040 INTRAUTERINE PRESSURE MONITORING KIT
K860101 · Medex, Inc. · Apr 1986
INTRAUTERINE CATHETER TIP
K790678 · Sonicaid, Inc. · May 1979