510(k) · Cleared

Recalled · Class II · 2014

Floor to Wall or Floor to Ceiling Tubestand;Radiog

K850198510(k) TraditionalCleared May 14, 1985116-day reviewClass I21 CFR 892.1770Recalls 1

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

Summit Industries, Inc. · IYB Tube Mount, X-Ray, Diagnostic

Cleared on May 14, 1985 after a 116-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.

Decided: May 14, 1985
Review: 116 days
Class: Class I
Product code: IYB
Recalls: 1
Predicates: 0

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

FIG. 1 — Lineage of K850198Source: 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.

Planning a device in IYB? 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?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 28, 2014	Class II	Z-0468-2015	Process control	The welds on J700 tube stands may be insufficient resulting in tube stand breakage, damage to the X-Ray machine, and/or patient or healthcare provider injury.

No ancestor or descendant has a Class I recall.

How does its category compare?

All IYB devices

IYB Tube Mount, X-Ray, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYB

FDA has decided no IYB device since 2007.

Median 510(k) review, days · IYB

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

Recalls per year · IYB

1in 2025

2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYB

1in 2018

2007high 4 (2009) · low 0 (2011)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	2
2008	—	0	2
2009	—	1	4
2010	—	0	1
2011	—	0	0
2012	—	0	1
2013	—	0	1
2014	—	1	0
2015	—	0	1
2016	—	0	0
2017	—	0	0
2018	—	0	1
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	1	0
2026	—	0	—

https://510kreport.com/device/K850198 · printed Nov 6, 2026

Cite this page

510(k) Report. “K850198: Floor to Wall or Floor to Ceiling Tubestand;Radiog.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K850198

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Record history

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