Koala®
Koala® Intrauterine Pressure Catheter with internal balloon
2manufacturers in China registered for this device type
2catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
Record
| Listed by | Clinical Innovations, LLC, United States |
|---|---|
| FDA product code | HFN |
| Device type | Transducer, Pressure, Intrauterine |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2700 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K974389 |
| Record published | 2016-09-01 |
| Record revised | 2025-10-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10, pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPC-5000C | In distribution | |
| IPC-5000E | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Koala® Cables | Clinical Innovations, LLC | 9 |
| Intran | Utah Medical Products, Inc. | 8 |
| Advanced Fetal Monitor | Advanced Instrumentations, Inc. | 1 |
| Transducer, Pressure, Intrauterine | Philips Medizin Systeme Böblingen GmbH | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250897 | 2025-05-22 |
| K974389 | 1998-02-19 |
| K973746 | 1997-11-24 |
| K954955 | 1996-04-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.