510(k) Report

510(k) · Cleared

Cleared

Mount Tube Radiographic

K853682510(k) TraditionalCleared Sep 19, 198515-day reviewClass I21 CFR 892.1770

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

X-Ray Systems · IYB Tube Mount, X-Ray, Diagnostic

Cleared on Sep 19, 1985 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 19, 1985
Review
15 days
Class
Class I
Product code
IYB
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K853682Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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)

No FDA recall names this device.

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

2009: 12014: 12025: 1
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

2007: 22008: 22009: 42010: 12012: 12013: 12015: 12018: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—02
20080—02
20090—14
20100—01
20110—00
20120—01
20130—01
20140—10
20150—01
20160—00
20170—00
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—10
20260—0—

More from X-Ray Systems

4 FDA decisions under this applicant name. See the company

  • K884493Head Holding Device/Sleep ApneaX-Ray Systems · 1989
  • K855161Upright Bucky Stand/MountX-Ray Systems · 1986
  • K855052Table Radiographic FixedX-Ray Systems · 1986

Recent decisions in IYB

The IYB category page

  • K935123Superstand 300Wuestec Medical, Inc. · 1996
  • K946261MTS-007, STS-008, Ssmts-010, Euro-40, 72, Super Euro 4072, 5000Scott Imaging Intl., Inc. · 1995
  • K941004CTS SystemAcoma Medical Imaging, Inc. · 1994
  • K941017F/C/W TubestandAcoma Medical Imaging, Inc. · 1994
  • K940442MPR-814Xri, Inc. · 1994

https://510kreport.com/device/K853682 · printed Nov 4, 2026

Cite this page

510(k) Report. “K853682: Mount Tube Radiographic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K853682

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