510(k) · Cleared
ClearedDRX5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axiom Usa., Inc. · ITH Equipment, Traction, Powered
Cleared on Dec 20, 2002 as substantially equivalent to K001712 (The Saunders Group, 2000) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1985. 4 later devices descend from it.
- Decided
- Dec 20, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K844385 (1985). 2 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK844385 Escotek Est Trac 401Nor-Am Patient Care Products, Inc. · 1985
- This deviceK023160 DRX5000Axiom Usa., Inc. · 2002
- Descendant · cites it directly · 0 of its ownK243366 DRX9000C-SL Cervical Spinal Decompression SystemExcite Medical of Tampa Bay, LLC · 2025
- Descendant · cites it directly · 0 of its ownK103248 Integrity Spinal Care SystemIntegra Life Sciences · 2011
- Descendant · cites it directly · 0 of its ownK073132 Model D Disc ForceNorth American Medical Corp (Nam) · 2008
- Descendant · cites it directly · 0 of its ownK051013 Spinemed S200B/S200CCert Health Sciences, LLC · 2005
Most influential descendants
Showing 4 of 4 · See all- K243366DRX9000C-SL Cervical Spinal Decompression SystemExcite Medical of Tampa Bay, LLC · 2025 · cites it directly0descendants
- K103248Integrity Spinal Care SystemIntegra Life Sciences · 2011 · cites it directly0descendants
- K073132Model D Disc ForceNorth American Medical Corp (Nam) · 2008 · cites it directly0descendants
- K051013Spinemed S200B/S200CCert Health Sciences, LLC · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K844385 | Escotek Est Trac 401 | Nor-Am Patient Care Products, Inc. | 1985 | — |
| 0 (this device) | K023160 | DRX5000 | Axiom Usa., Inc. | 2002 | — |
| +1 | K243366 | DRX9000C-SL Cervical Spinal Decompression System | Excite Medical of Tampa Bay, LLC | 2025 | — |
| +1 | K103248 | Integrity Spinal Care System | Integra Life Sciences | 2011 | — |
| +1 | K073132 | Model D Disc Force | North American Medical Corp (Nam) | 2008 | — |
| +1 | K051013 | Spinemed S200B/S200C | Cert Health Sciences, LLC | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2025 | 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 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? (2)
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 |
|---|---|---|---|
| * | K001712 | 3D Activetrac | 2000 |
| * | K844385 | Escotek Est Trac 401Summary page 1…89 ITH Panel Code: 87 ORS Predicate Devices: KO01 712 3-0Active Trac - Saunders Group K844385 Tm-Trac 401 Traction - HenIey International Proposed Intended Use The DRX5000 provides a program of treatments for relief from… | 1985 |
| † | K951622 | Vax-D Therapeutic Table | 1996 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 | — |
What is it indicated for?
The DRX5000 provides a program of treatments for relief from pain for those patients suffering with low back pain and neck pain. Each treatment consists of a physician prescribed treatment period on the DRX5000 and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back or neck pain. Conditions that may be treated include neck pain and back pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023160 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023160: DRX5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023160
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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