510(k) · Cleared
ClearedKoala Intrauterine Pressure Catheter (IPC-5000E)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinical Innovations, LLC · HFN Transducer, Pressure, Intrauterine
Cleared on May 22, 2025 as substantially equivalent to K974389 (Clinical Innovations, Inc., 1998) after a 58-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- May 22, 2025
- Review
- 58 days
- Class
- Class II
- Product code
- HFN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974389 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK974389 Koala Intrauterine Pressure Catheter, Koala External Intrauterine…Clinical Innovations, Inc. · 1998
- This deviceK250897 Koala Intrauterine Pressure Catheter (IPC-5000E)Clinical Innovations, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974389 | Koala Intrauterine Pressure Catheter, Koala External Intrauterine Pressure… | Clinical Innovations, Inc. | 1998 | — |
| 0 (this device) | K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E) | Clinical Innovations, LLC | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HFN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K974389 | Koala Intrauterine Pressure Catheter, Koala External Intrauterine Pressure CatheterSummary page 5…ss: Class II Predicate Device Information Device Name: Koala Intrauterine Pressure Catheter 510(k) Number K974389 Manufacturer: Clinical Innovations LLC The predicate device has not been subject to a design-related recal… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All HFN devicesHFN Transducer, Pressure, Intrauterine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · HFN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HFN
Too few HFN 510(k)s in any year since 2007 to give a median.
Recalls per year · HFN
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HFN
4in 2024
MAUDE reports naming product code HFN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Koala Intrauterine Pressure Catheter is indicated for use on patients requiring intrapartum intrauterine pressure monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250897 · printed Nov 5, 2026
Cite this page
510(k) Report. “K250897: Koala Intrauterine Pressure Catheter (IPC-5000E).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K250897
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026