510(k) · Cleared
ClearedSoftrans Intrauterine Pressure Catheter System (Iup 4000 Softrans Iupc)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Graphic Controls Corp. · KXO Monitor, Pressure, Intrauterine
Cleared on Jan 22, 1997 after an 86-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jan 22, 1997
- Review
- 86 days
- Class
- Class II
- Product code
- KXO
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK964279 Softrans Intrauterine Pressure Catheter System (Iup 4000 Softrans…Graphic Controls Corp. · 1997
- Descendant · cites it directly · 0 of its ownK982565 Easy Trans TipCarl Schuh · 1998
Most influential descendants
Showing 1 of 1 · See all- K982565Easy Trans TipCarl Schuh · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964279 | Softrans Intrauterine Pressure Catheter System (Iup 4000 Softrans Iupc) | Graphic Controls Corp. | 1997 | — |
| +1 | K982565 | Easy Trans Tip | Carl Schuh | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
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 KXO? 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 |
|---|---|---|---|
| * | — | Softrans™ Intrauterine Pressure Catheter System Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982565 | Easy Trans Tip | 1998 | 0 |
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?
- Of its descendants, K982565 (Carl Schuh, 1998) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KXO devicesKXO Monitor, Pressure, Intrauterine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KXO
FDA has decided no KXO device since 2007.
Median 510(k) review, days · KXO
Too few KXO 510(k)s in any year since 2007 to give a median.
Recalls per year · KXO
No recall names KXO since 2007.
Adverse event reports per year · KXO
1in 2015
MAUDE reports naming product code KXO, 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 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Intended for use in measuring the intensity, duration, and frequency of uterine contractions during labor. Also, the catheter may be used for amnioinfusion of fluid into the uterus or to sample amniotic fluid.
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/K964279 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964279: Softrans Intrauterine Pressure Catheter System (Iup 4000 Softrans Iupc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964279
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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