Product code HFN
- Device name
- Transducer, Pressure, Intrauterine
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.2700
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E) | Clinical Innovations, LLC | 2025-05-22 |
| K974389 | KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER | Clinical Innovations, Inc. | 1998-02-19 |
| K973746 | PRE-FILLED SYRINGE FOR KOALA IUP | Clinical Innovations, Inc. | 1997-11-24 |
| K961424 | INTRAN 500 | Utah Medical Products, Inc. | 1996-07-10 |
| K954955 | STORC INTRAUTERINE PRESSURE CATHETER | Clinical Innovations, Inc. | 1996-04-17 |
| K955443 | INTRAN PLUS | Utah Medical Products, Inc. | 1996-02-20 |
| K920375 | DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER | Telos Medical Corp. | 1992-10-27 |
| K882224 | ULTRANS DISPOSABLE INTRAUTERINE | Telos Medical Corp. | 1989-10-12 |
| K893503 | SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS | Laurel Medical Corp. | 1989-06-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00884838093188 | Avalon Toco+ MP Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838093195 | Avalon Ultrasound Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838093201 | Avalon ECG/IUP Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838093218 | Avalon Toco MP Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838093225 | Avalon Toco+ Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| B510FM30001 | ADVANCED FETAL MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| 00884838001404 | NA | Philips Medizin Systeme Böblingen GmbH | 2016-11-21 |
| H671IUP4500 | INTRAN | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671IUP7501 | INTRAN | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671IUP7001 | INTRAN | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671IUP6501 | INTRAN | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671IUP6001 | INTRAN | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671IUP5501 | INTRAN | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671IUP5001 | INTRAN | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671IUP4501 | INTRAN | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671IUP4001 | INTRAN | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671IUP7500 | INTRAN | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671IUP7000 | INTRAN | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671IUP6500 | INTRAN | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671IUP6000 | INTRAN | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671IUP5500 | INTRAN | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671IUP5000 | INTRAN | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671IUP4000 | INTRAN | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| 00814247020178 | Koala® | CLINICAL INNOVATIONS, LLC | 2016-09-01 |
| 00814247020154 | Koala® | CLINICAL INNOVATIONS, LLC | 2016-09-01 |
| 20814247020172 | Koala® | CLINICAL INNOVATIONS, LLC | 2016-09-01 |
| 00814247020192 | Koala® Cables | CLINICAL INNOVATIONS, LLC | 2016-09-01 |
| 00814247020208 | Koala® Cables | CLINICAL INNOVATIONS, LLC | 2016-09-01 |
| 00814247020215 | Koala® Cables | CLINICAL INNOVATIONS, LLC | 2016-09-01 |
| 00814247020222 | Koala® Cables | CLINICAL INNOVATIONS, LLC | 2016-09-01 |