510(k) · Cleared

Recalled · 2008

Intran Plus

K905563510(k) TraditionalCleared Jun 19, 1991189-day reviewClass II21 CFR 884.2700Recalls 1

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

Utah Medical Products, Inc. · KXO Monitor, Pressure, Intrauterine

Cleared on Jun 19, 1991 after a 189-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided: Jun 19, 1991
Review: 189 days
Class: Class II
Product code: KXO
Recalls: 1
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK905563 Intran PlusUtah Medical Products, Inc. · 1991
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)	K905563	Intran Plus	Utah Medical Products, Inc.	1991	—
+1	K982565	Easy Trans Tip	Carl Schuh	1998	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K905563, 1991–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K982565	Easy Trans Tip	Carl Schuh	1998	0

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.

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 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	—	—

https://510kreport.com/device/K905563 · printed Nov 6, 2026

Cite this page

510(k) Report. “K905563: Intran Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905563

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026