510(k) · Cleared
ClearedVERT-X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Direx Systems Corp. · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Aug 18, 2006 as substantially equivalent to K053640 (Direx Systems Corp., 2006) after a 46-day review. Its family tree reaches back 5 generations to 1984.
- Decided
- Aug 18, 2006
- Review
- 46 days
- Class
- Class II
- Product code
- OXO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to P840008 (1984). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backP840008 Dornier Lithotripter Compact Transportable (DLCT)Dornier Medtech America, Inc. · 1984
- 4 generations backK011873 Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli…Dornier · 2001
- 3 generations backK040470 Tripter X-1 CompactDirex Systems Corp. · 2004
- 2 generations backK041582 Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 2004
- 1 generation backK053640 IntegraDirex Systems Corp. · 2006
- This deviceK061873 VERT-XDirex Systems Corp. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | P840008 | Dornier Lithotripter Compact Transportable (DLCT) | Dornier Medtech America, Inc. | 1984 | — |
| −4 | K011873 | Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP) | Dornier | 2001 | — |
| −3 | K040470 | Tripter X-1 Compact | Direx Systems Corp. | 2004 | — |
| −2 | K041582 | Modification to Tripter X-1 Compact Duet | Direx Systems Corp. | 2004 | — |
| −1 | K053640 | Integra | Direx Systems Corp. | 2006 | — |
| 0 (this device) | K061873 | VERT-X | Direx Systems Corp. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OXO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OXO device
- #1 K253296 Digital C-ARM with 3Dscore 15.1 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K053640 | IntegraSummary page 1…Class: Class 1I (special controsls Product code: 90 JAA Panel: Radiology 3. Predicate Devices Direx 3Dscope (K053640) 5-1 4. Intended Use: Vert-X is a mobile apparatus used for fluoroscopi… | 2006 |
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.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 16 ancestors has a recall.
- 3 other devices also cite its predicate K053640.
How does its category compare?
All OXO devicesOXO Image-Intensified Fluoroscopic X-Ray System, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OXO
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OXO
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OXO
4in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OXO
118in 2025
MAUDE reports naming product code OXO, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 48 | 4 | 5 |
| 2013 | 2 | — | 3 | 41 |
| 2014 | 2 | — | 4 | 89 |
| 2015 | 1 | — | 0 | 97 |
| 2016 | 3 | 128 | 3 | 3,820 |
| 2017 | 4 | 57 | 4 | 1,697 |
| 2018 | 1 | — | 11 | 1,647 |
| 2019 | 3 | 213 | 0 | 1,297 |
| 2020 | 0 | — | 0 | 816 |
| 2021 | 2 | — | 0 | 554 |
| 2022 | 0 | — | 0 | 295 |
| 2023 | 0 | — | 0 | 275 |
| 2024 | 2 | — | 4 | 192 |
| 2025 | 4 | 97 | 0 | 118 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Vert-X is a mobile apparatus used for fluoroscopic examination of a patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061873 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061873: VERT-X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061873
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026