510(k) · Cleared

Cleared

Easy Trans Tip

K982565510(k) TraditionalCleared Sep 22, 199861-day reviewClass II21 CFR 884.2700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Carl Schuh · KXO Monitor, Pressure, Intrauterine

Cleared on Sep 22, 1998 as substantially equivalent to K961290 (Scientific Device Manufacturer, LLC, 1996) and 3 other predicates after a 61-day review. Its family tree reaches back 1 generation to 1991.

Decided: Sep 22, 1998
Review: 61 days
Class: Class II
Product code: KXO
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K905563 (1991). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK905563 Intran PlusUtah Medical Products, Inc. · 1991 · Recalled
This deviceK982565 Easy Trans TipCarl Schuh · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K905563	Intran Plus	Utah Medical Products, Inc.	1991	1
0 (this device)	K982565	Easy Trans Tip	Carl Schuh	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
1997	1	0

FIG. 1 — Lineage of K982565, 1991–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (5)

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	Applicant	Decided	Recalls
*	K961290	Iup - Tip Trans, Iup - Proxi Trans Summary page 1 …e Pressure Transducer Catheter (IUPC) Classification Name: Intrauterine pressure Transducer Equivalent Device(s): 3 Scientific Device Manufacturer, “Tip Trans” 510(k) # K 961290 Utah Medical, “IntransPlus IUP-400” 510(k) #K 905563/A and K 955443 Graphic Control, “Softrans 4000 IUPC” 510(k) #K 964279 Class…	Scientific Device Manufacturer, LLC	1996	—
*	K905563	Intran Plus Summary page 1 …ame: Intrauterine pressure Transducer Equivalent Device(s): 3 Scientific Device Manufacturer, “Tip Trans” 510(k) # K 961290 Utah Medical, “IntransPlus IUP-400” 510(k) #K 905563/A and K 955443 Graphic Control, “Softrans 4000 IUPC” 510(k) #K 964279 Classification: It has been determined that devices of thi…	Utah Medical Products, Inc.	1991	1
*	K955443	Intran Plus Summary page 1 …ne pressure Transducer Equivalent Device(s): 3 Scientific Device Manufacturer, “Tip Trans” 510(k) # K 961290 Utah Medical, “IntransPlus IUP-400” 510(k) #K 905563/A and K 955443 Graphic Control, “Softrans 4000 IUPC” 510(k) #K 964279 Classification: It has been determined that devices of this generic type…	Utah Medical Products, Inc.	1996	1
*	K964279	Softrans Intrauterine Pressure Catheter System (Iup 4000 Softrans Iupc) Summary page 1 …fic Device Manufacturer, “Tip Trans” 510(k) # K 961290 Utah Medical, “IntransPlus IUP-400” 510(k) #K 905563/A and K 955443 Graphic Control, “Softrans 4000 IUPC” 510(k) #K 964279 Classification: It has been determined that devices of this generic type have been previously classified as CLASS II Devices. P…	Graphic Controls Corp.	1997	—
*	—	Hewlett Packard 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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 4 ancestors have a recall of any class.

How does its category compare?

All KXO devices

KXO 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

2007high 2 (2008) · low 0 (2007)2025

MAUDE reports naming product code KXO, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	2
2009	—	2
2010	—	0
2011	—	1
2012	—	0
2013	—	0
2014	—	0
2015	—	1
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

This intrauterine pressure monitoring catheter (IUPC) is for use on patients requiring intrapartum intrauterine pressure monitoring. Additionally it may be used for amniofusion and for amniotic fluid sampling.

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/K982565 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982565: Easy Trans Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982565

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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