HFN · Transducer, Pressure, Intrauterine
Obstetrics/Gynecology · 21 CFR 884.2700 · Class 2
Overview
| Product Code | HFN |
|---|---|
| Device Name | Transducer, 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 (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E) | Clinical Innovations, LLC | May 22, 2025 | SESE |
| K974389 | KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER | Clinical Innovations, Inc. | Feb 19, 1998 | SESE |
| K973746 | PRE-FILLED SYRINGE FOR KOALA IUP | Clinical Innovations, Inc. | Nov 24, 1997 | SESE |
| K961424 | INTRAN 500 | Utah Medical Products, Inc. | Jul 10, 1996 | SESE |
| K954955 | STORC INTRAUTERINE PRESSURE CATHETER | Clinical Innovations, Inc. | Apr 17, 1996 | SESE |
| K955443 | INTRAN PLUS | Utah Medical Products, Inc. | Feb 20, 1996 | SESE |
| K920375 | DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER | Telos Medical Corp. | Oct 27, 1992 | SESE |
| K882224 | ULTRANS DISPOSABLE INTRAUTERINE | Telos Medical Corp. | Oct 12, 1989 | SESE |
| K893503 | SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS | Laurel Medical Corp. | Jun 12, 1989 | SESE |
Top Applicants
- Clinical Innovations, Inc. — 3 clearances
- Telos Medical Corp. — 2 clearances
- Utah Medical Products, Inc. — 2 clearances
- Clinical Innovations, LLC — 1 clearance
- Laurel Medical Corp. — 1 clearance
