Medebar Xac-90

K800842510(k) TraditionalCleared May 30, 198045-day reviewClass U

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

Medefield Pty., Ltd. · KTA Medium, Contrast, Radiologic

Cleared on May 30, 1980 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided: May 30, 1980
Review: 45 days
Class: Class U
Product code: KTA
Recalls: None
Predicates: 0

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

FIG. 1 — Lineage of K800842Source: FDA 510(k) database · 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.

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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?

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.

How does its category compare?

All KTA devices

KTA Medium, Contrast, Radiologic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KTA

FDA has decided no KTA device since 2007.

Median 510(k) review, days · KTA

Too few KTA 510(k)s in any year since 2007 to give a median.

Recalls per year · KTA

No recall names KTA since 2007.

Adverse event reports per year · KTA

4in 2018

2007high 7 (2007) · low 0 (2013)2025

MAUDE reports naming product code KTA, 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	—	7
2008	—	2
2009	—	2
2010	—	2
2011	—	4
2012	—	1
2013	—	0
2014	—	0
2015	—	0
2016	—	1
2017	—	1
2018	—	4
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K800842 · printed Nov 4, 2026

Cite this page

510(k) Report. “K800842: Medebar Xac-90.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K800842

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Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026