510(k) · Cleared
Recalled · 2008Intran 500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Utah Medical Products, Inc. · HFN Transducer, Pressure, Intrauterine
Cleared on Jul 10, 1996 after an 89-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- Jul 10, 1996
- Review
- 89 days
- Class
- Class II
- Product code
- HFN
- Recalls
- 1
- Predicates
- 0
The FDA summary names its predicate without a number.
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.
Top candidate predicates for a new HFN device
- #1 K250897 Koala Intrauterine Pressure Catheter (IPC-5000E)score 9.4 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | — | Intran-400 Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 16, 2008 | Not classified | Z-2200-2008 | Component change control | Possibility of compromised package sterility prior to the expiration date. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All HFN devicesHFN Transducer, Pressure, Intrauterine: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The UMP Intran 500 is the same device as Intran 400, Intran Plus, a sensor-tipped intrauterine pressure catheter used by obstetricians in monitoring the frequency and duration of contractions during labor and delivery, primarily indicated in “high risk” births.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961424: Intran 500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961424
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026