510(k) · Cleared
ClearedIup - Tip Trans, Iup - Proxi Trans
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scientific Device Manufacturer, LLC · KXO Monitor, Pressure, Intrauterine
Cleared on Oct 15, 1996 after a 194-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Oct 15, 1996
- Review
- 194 days
- Class
- Class II
- Product code
- KXO
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK961290 Iup - Tip Trans, Iup - Proxi TransScientific Device Manufacturer, LLC · 1996
- 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) | K961290 | Iup - Tip Trans, Iup - Proxi Trans | Scientific Device Manufacturer, LLC | 1996 | — |
| +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? (3)
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 |
|---|---|---|---|
| * | — | IntranPlus (Utah Medical) Named without a submission number | |
| * | — | Fetal Monitoring Intrauterine Pressure Kit, #14099C (Hewlett Packard) Named without a submission number | |
| * | — | Corometrics 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?
The intrauterine pressure monitoring catheter (IUP) is for use on patients requiring intrapartum intrauterine monitoring, amniofusion, and sampling of 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/K961290 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961290: Iup - Tip Trans, Iup - Proxi Trans.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961290
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)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026