Koala Intrauterine Pressure Catheter (IPC-5000E)
FDA 510(k) K250897 · Clinical Innovations, LLC
510(k) numberK250897
Submission
- Device name
- Koala Intrauterine Pressure Catheter (IPC-5000E)
- Applicant
- Clinical Innovations, LLC
Murray, UT, US - Received
- March 25, 2025
- Decision date
- May 22, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HFN – Transducer, Pressure, Intrauterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2700
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HFN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974389 | Koala Intrauterine Pressure Catheter, Koala External Intrauterine Pressure CatheterHFN · Traditional | Clinical Innovations, Inc. | 02/19/1998SE |
| K973746 | Pre-Filled Syringe for Koala IupHFN · Traditional | Clinical Innovations, Inc. | 11/24/1997SE |
| K961424 | Intran 500HFN · Traditional | Utah Medical Products, Inc. | 07/10/1996SE |
| K954955 | Storc Intrauterine Pressure CatheterHFN · Traditional | Clinical Innovations, Inc. | 04/17/1996SE |
| K955443 | Intran PlusHFN · Traditional | Utah Medical Products, Inc. | 02/20/1996SE |
| K920375 | Disposable Intrauterine Pressure TransducerHFN · Traditional | Telos Medical Corp. | 10/27/1992SE |
| K882224 | Ultrans Disposable IntrauterineHFN · Traditional | Telos Medical Corp. | 10/12/1989SE |
| K893503 | Sofsens(Tm) Model LMP-100 Intrauterine Pres. TransHFN · Traditional | Laurel Medical Corp. | 06/12/1989SE |
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| K250298 | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum…HDB · Traditional | 10/08/2025SE |
| K223900 | babyLance Safety Heelstick (BLM, BLN, BLP)FMK · Traditional | 02/24/2023SE |
| K153591 | ebb Complete Tamponade SystemOQY · Special | 01/14/2016SE |
| K150573 | ebb Complete Tamponade SystemOQY · Special | 03/25/2015SE |
| K140163 | Koala TocoHFM · Traditional | 05/29/2014SE |
| K131781 | Clearview TotalLKF · Traditional | 05/28/2014SE |
| K110605 | Rom PlusNQM · Traditional | 11/23/2011SE |
| K061539 | Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision DeviceHFX · Traditional | 09/20/2007SE |
| K030691 | Fetal Spiral Electrode, Model FSE07000HGP · Traditional | 09/17/2003SE |
| K022023 | Compass Esophageal Pressure Catheter, Model GIE-8500, Compass Ano-Rectal Pressure…KLA · Traditional | 01/07/2003SE |
Questions and answers
When was Koala Intrauterine Pressure Catheter (IPC-5000E) cleared by the FDA?
Koala Intrauterine Pressure Catheter (IPC-5000E) (K250897) received a 510(k) decision of Substantially Equivalent on May 22, 2025, 58 days after the submission was received.
What is the product code of K250897?
The FDA product code is HFN – Transducer, Pressure, Intrauterine, a Class II (moderate risk) device regulated under 21 CFR 884.2700.