Transducer, Pressure, Intrauterine
The Intrauterine Pressure Transducer is a device inserted into the uterine cavity to directly measure intrauterine pressure, providing quantitative data on the strength and timing of uterine contractions during labor. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HFN, regulated under 21 CFR 884.2700, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- HFN
- 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 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E) | May 22, 2025 | Substantially Equivalent | Clinical Innovations, LLC |
| K974389 | KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER | Feb 19, 1998 | Substantially Equivalent | Clinical Innovations, Inc. |
| K973746 | PRE-FILLED SYRINGE FOR KOALA IUP | Nov 24, 1997 | Substantially Equivalent | Clinical Innovations, Inc. |
| K961424 | INTRAN 500 | Jul 10, 1996 | Substantially Equivalent | Utah Medical Products, Inc. |
| K954955 | STORC INTRAUTERINE PRESSURE CATHETER | Apr 17, 1996 | Substantially Equivalent | Clinical Innovations, Inc. |
| K955443 | INTRAN PLUS | Feb 20, 1996 | Substantially Equivalent | Utah Medical Products, Inc. |
| K920375 | DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER | Oct 27, 1992 | Substantially Equivalent | Telos Medical Corp. |
| K882224 | ULTRANS DISPOSABLE INTRAUTERINE | Oct 12, 1989 | Substantially Equivalent | Telos Medical Corp. |
| K893503 | SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS | Jun 12, 1989 | Substantially Equivalent | Laurel Medical Corp. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.