Monitor, Pressure, Intrauterine
The Intrauterine Pressure Monitor is a device used during labor to measure uterine contraction pressure by means of a catheter or sensor placed within the uterine cavity, providing data on contraction frequency, duration, and intensity to guide labor management. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KXO, regulated under 21 CFR 884.2700, in the Obstetrics/Gynecology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
Research product code KXO in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- KXO
- Device Class
- FDA class 2
- Regulation Number
- 884.2700
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 26 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K991235 | SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) | Jul 08, 1999 | Substantially Equivalent | Ludlow Technical Products |
| K982565 | EASY TRANS TIP | Sep 22, 1998 | Substantially Equivalent | Carl Schuh |
| K974730 | SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC) | Jul 14, 1998 | Substantially Equivalent | Graphic Controls Corp. |
| K964279 | SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) | Jan 22, 1997 | Substantially Equivalent | Graphic Controls Corp. |
| K961290 | IUP - TIP TRANS, IUP - PROXI TRANS | Oct 15, 1996 | Substantially Equivalent | Scientific Device Manufacturer, LLC |
| K950498 | LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER | Jul 24, 1995 | Substantially Equivalent | Graphic Controls Corp. |
| K950708 | LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 | May 25, 1995 | Substantially Equivalent | Graphic Controls Corp. |
| K922323 | MX4042/MC4044 SERIES SIMULCATH(TM) | Jun 14, 1994 | Substantially Equivalent | Medex, Inc. |
| K920044 | DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT | Apr 03, 1992 | Substantially Equivalent | Telos Medical Corp. |
| K910742 | MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER | Jan 14, 1992 | Substantially Equivalent | Graphic Controls Corp. |
| K905563 | INTRAN PLUS | Jun 19, 1991 | Substantially Equivalent | Utah Medical Products, Inc. |
| K910227 | MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER | Apr 03, 1991 | Substantially Equivalent | Medex, Inc. |
| K901084 | ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. | Jun 01, 1990 | Substantially Equivalent | Healthdyne Cardiovascular, Inc. |
| K896122 | AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED | Jan 19, 1990 | Substantially Equivalent | Spectramed, Inc. |
| K895763 | ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING | Dec 22, 1989 | Substantially Equivalent | Healthdyne Cardiovascular, Inc. |
| K895323 | MODEL DT-BAL, BALANCE SAVER | Oct 24, 1989 | Substantially Equivalent | Spectramed, Inc. |
| K894362 | MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP | Aug 15, 1989 | Substantially Equivalent | Spectramed, Inc. |
| K885316 | DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A | Mar 23, 1989 | Substantially Equivalent | Hewlett-Packard Co. |
| K881857 | AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. | Feb 01, 1989 | Substantially Equivalent | Spectramed, Inc. |
| K883832 | CATHETER, INTRAUTERINE AND INTRODUCER | Dec 13, 1988 | Substantially Equivalent | Telos Medical Corp. |
| K862873 | IUC - INTRAUTERINE CATHETER | Feb 26, 1987 | Substantially Equivalent | Utah Medical Products, Inc. |
| K862182 | AMNIOINFUSION CATHETER | Aug 25, 1986 | Substantially Equivalent | Michael Reese Hospital and Medical Center |
| K860101 | MX4040 INTRAUTERINE PRESSURE MONITORING KIT | Apr 14, 1986 | Substantially Equivalent | Medex, Inc. |
| K801758 | MMI/GAELTEC CATHETER INTRAUTERINE | Aug 14, 1980 | Substantially Equivalent | Medical Measurements, Inc. |
| K790678 | INTRAUTERINE CATHETER TIP | May 11, 1979 | Substantially Equivalent | Sonicaid, Inc. |
| K790418 | MODEL 8100 PRE-FILLED INTRAUTERINE | Mar 21, 1979 | Substantially Equivalent | Ge Medical Systems Information Technologies |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.