510(k) · Cleared
ClearedDRX 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axiom Worldwide, Inc. · ITH Equipment, Traction, Powered
Cleared on May 1, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- May 1, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK010292 DRX 2000Axiom Worldwide, Inc. · 2001
- Descendant · cites it directly · 4 of its ownK022602 DRX3000Axiom Usa., Inc. · 2003
- Descendant · 2 generations on · 3 of its ownK060735 DRX9000 True Spinal Decompression SystemAxiom Worldwide, Inc. · 2006
- Descendant · 3 generations on · 0 of its ownK243775 True Non-Surgical Spinal Decompression System (DRX9000-SL)Excite Medical of Tampa Bay, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK130249 Integrity Spinal Care System 3.0Integrity Life Sciences · 2014
- Descendant · 3 generations on · 0 of its ownK073132 Model D Disc ForceNorth American Medical Corp (Nam) · 2008
Most influential descendants
Showing 5 of 5 · See all- K022602DRX3000Axiom Usa., Inc. · 2003 · cites it directly4descendants
- K060735DRX9000 True Spinal Decompression SystemAxiom Worldwide, Inc. · 2006 · 2 generations on3descendants
- K243775True Non-Surgical Spinal Decompression System (DRX9000-SL)Excite Medical of Tampa Bay, LLC · 2025 · 3 generations on0descendants
- K130249Integrity Spinal Care System 3.0Integrity Life Sciences · 2014 · 3 generations on0descendants
- K073132Model D Disc ForceNorth American Medical Corp (Nam) · 2008 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010292 | DRX 2000 | Axiom Worldwide, Inc. | 2001 | — |
| +1 | K022602 | DRX3000 | Axiom Usa., Inc. | 2003 | — |
| +2 | K060735 | DRX9000 True Spinal Decompression System | Axiom Worldwide, Inc. | 2006 | — |
| +3 | K243775 | True Non-Surgical Spinal Decompression System (DRX9000-SL) | Excite Medical of Tampa Bay, LLC | 2025 | — |
| +3 | K130249 | Integrity Spinal Care System 3.0 | Integrity Life Sciences | 2014 | — |
| +3 | K073132 | Model D Disc Force | North American Medical Corp (Nam) | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2025 | 1 | 0 |
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 ITH? 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 ITH device
- #1 K243775 True Non-Surgical Spinal Decompression System…score 10.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022602 | DRX3000 | 2003 | 4 |
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?
- Of its descendants, K022602 (Axiom Usa., Inc., 2003) has gone furthest, with 4 descendants of its own.
How does its category compare?
All ITH devicesITH Equipment, Traction, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITH
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITH
132in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITH
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ITH
3in 2025
MAUDE reports naming product code ITH, 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 | 2 | — | 0 | 2 |
| 2008 | 4 | 132 | 0 | 0 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 2 | 5 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 5 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K010292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010292: DRX 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010292
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026