KXO · Monitor, Pressure, Intrauterine
Obstetrics/Gynecology · 21 CFR 884.2700 · Class 2
Overview
| Product Code | KXO |
|---|---|
| Device Name | Monitor, Pressure, Intrauterine |
| Regulation | 21 CFR 884.2700 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
An intrauterine pressure monitor is a device designed to detect and measure intrauterine and amniotic fluid pressure with a catheter placed transcervically into the uterine cavity. The device is used to monitor intensity, duration, and frequency of uterine contractions during labor. This generic type of device may include the following accessories: signal analysis and display equipment, patient and equipment supports, and component parts.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 26)
Showing 20 most recent of 26 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K991235 | SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) | Ludlow Technical Products | Jul 8, 1999 | SESE |
| K982565 | EASY TRANS TIP | Carl Schuh | Sep 22, 1998 | SESE |
| K974730 | SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC) | Graphic Controls Corp. | Jul 14, 1998 | SESE |
| K964279 | SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) | Graphic Controls Corp. | Jan 22, 1997 | SESE |
| K961290 | IUP - TIP TRANS, IUP - PROXI TRANS | Scientific Device Manufacturer, LLC | Oct 15, 1996 | SESE |
| K950498 | LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER | Graphic Controls Corp. | Jul 24, 1995 | SESE |
| K950708 | LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 | Graphic Controls Corp. | May 25, 1995 | SESE |
| K922323 | MX4042/MC4044 SERIES SIMULCATH(TM) | Medex, Inc. | Jun 14, 1994 | SESE |
| K920044 | DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT | Telos Medical Corp. | Apr 3, 1992 | SESE |
| K910742 | MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER | Graphic Controls Corp. | Jan 14, 1992 | SESE |
| K905563 | INTRAN PLUS | Utah Medical Products, Inc. | Jun 19, 1991 | SESE |
| K910227 | MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER | Medex, Inc. | Apr 3, 1991 | SESE |
| K901084 | ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. | Healthdyne Cardiovascular, Inc. | Jun 1, 1990 | SESE |
| K896122 | AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED | Spectramed, Inc. | Jan 19, 1990 | SESE |
| K895763 | ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING | Healthdyne Cardiovascular, Inc. | Dec 22, 1989 | SESE |
| K895323 | MODEL DT-BAL, BALANCE SAVER | Spectramed, Inc. | Oct 24, 1989 | SESE |
| K894362 | MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP | Spectramed, Inc. | Aug 15, 1989 | SESE |
| K885316 | DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A | Hewlett-Packard Co. | Mar 23, 1989 | SESE |
| K881857 | AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. | Spectramed, Inc. | Feb 1, 1989 | SESE |
| K883832 | CATHETER, INTRAUTERINE AND INTRODUCER | Telos Medical Corp. | Dec 13, 1988 | SESE |
Top Applicants
- Graphic Controls Corp. — 5 clearances
- Spectramed, Inc. — 4 clearances
- Medex, Inc. — 3 clearances
- Healthdyne Cardiovascular, Inc. — 2 clearances
- Telos Medical Corp. — 2 clearances
