510(k) · Cleared
Recalled · 2010Hydrajust IV Urological Table
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mallinckrodt Group, Inc. · IXR Table, Radiographic, Tilting
Cleared on Apr 27, 1992 after a 68-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled once.
- Decided
- Apr 27, 1992
- Review
- 68 days
- Class
- Class II
- Product code
- IXR
- Recalls
- 1
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 IXR? 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
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, 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 |
|---|---|---|---|---|
| Jun 14, 2010 | Not classified | Z-1904-2010 | Process control | Covidien received complaints of the Sedecal Generator failing and producing smoke at customer sites. The failure modes are located in different parts of the generator and will lead to the generator becoming inoperative. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All IXR devicesIXR Table, Radiographic, Tilting: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IXR
FDA has decided no IXR device since 2007.
Median 510(k) review, days · IXR
Too few IXR 510(k)s in any year since 2007 to give a median.
Recalls per year · IXR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IXR
1in 2024
MAUDE reports naming product code IXR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 4 |
| 2008 | 0 | — | 4 | 8 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 5 | 12 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 164 |
| 2013 | 0 | — | 0 | 196 |
| 2014 | 0 | — | 0 | 120 |
| 2015 | 0 | — | 0 | 82 |
| 2016 | 0 | — | 1 | 58 |
| 2017 | 0 | — | 1 | 25 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 1 | 8 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K920742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K920742: Hydrajust IV Urological Table.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920742
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026