510(k) · Cleared
ClearedDRX3000
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 Jan 23, 2003 as substantially equivalent to K010292 (Axiom Worldwide, Inc., 2001) and 2 other predicates after a 170-day review. Its family tree reaches back 2 generations to 1989. 4 later devices descend from it.
- Decided
- Jan 23, 2003
- Review
- 170 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K894435 (1989). 4 ancestors in all, the oldest K844385 (1985). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK894435 Vax-T Pelvic Traction BeltVat-Tech, Inc. · 1989
- 1 generation backK951622 Vax-D Therapeutic TableVat-Tech, Inc. · 1996
- This deviceK022602 DRX3000Axiom Usa., Inc. · 2003
- Descendant · cites it directly · 3 of its ownK060735 DRX9000 True Spinal Decompression SystemAxiom Worldwide, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK243775 True Non-Surgical Spinal Decompression System (DRX9000-SL)Excite Medical of Tampa Bay, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK130249 Integrity Spinal Care System 3.0Integrity Life Sciences · 2014
- Descendant · 2 generations on · 0 of its ownK073132 Model D Disc ForceNorth American Medical Corp (Nam) · 2008
Most influential descendants
Showing 4 of 4 · See all- K060735DRX9000 True Spinal Decompression SystemAxiom Worldwide, Inc. · 2006 · cites it directly3descendants
- K243775True Non-Surgical Spinal Decompression System (DRX9000-SL)Excite Medical of Tampa Bay, LLC · 2025 · 2 generations on0descendants
- K130249Integrity Spinal Care System 3.0Integrity Life Sciences · 2014 · 2 generations on0descendants
- K073132Model D Disc ForceNorth American Medical Corp (Nam) · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894435 | Vax-T Pelvic Traction Belt | Vat-Tech, Inc. | 1989 | — |
| −1 | K951622 | Vax-D Therapeutic Table | Vat-Tech, Inc. | 1996 | — |
| 0 (this device) | K022602 | DRX3000 | Axiom Usa., Inc. | 2003 | — |
| +1 | K060735 | DRX9000 True Spinal Decompression System | Axiom Worldwide, Inc. | 2006 | — |
| +2 | K243775 | True Non-Surgical Spinal Decompression System (DRX9000-SL) | Excite Medical of Tampa Bay, LLC | 2025 | — |
| +2 | K130249 | Integrity Spinal Care System 3.0 | Integrity Life Sciences | 2014 | — |
| +2 | K073132 | Model D Disc Force | North American Medical Corp (Nam) | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 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? (3)
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 |
|---|---|---|---|
| * | K010292 | DRX 2000 | 2001 |
| * | K844385 | Escotek Est Trac 401Summary page 1…Class I1 (2 1 CFR Section 890.5900) Product Code: 89 ITH Predicate Devices: KO10292 DRX2000 - Axiom Worldwide K844385 Tru-True 401 Traction - Henley International K951622 VAX-DB Therapeutic Table - Vat-Tech, Inc. Proposed Intended Use… | 1985 |
| * | K951622 | Vax-D Therapeutic TableSummary page 1…89 ITH Predicate Devices: KO10292 DRX2000 - Axiom Worldwide K844385 Tru-True 401 Traction - Henley International K951622 VAX-DB Therapeutic Table - Vat-Tech, Inc. Proposed Intended Use The DRX3000 provides a program of treatments for relief from p… | 1996 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060735 | DRX9000 True Spinal Decompression System | 2006 | 3 |
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 14 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K060735 (Axiom Worldwide, Inc., 2006) has gone furthest, with 3 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 | — |
What is it indicated for?
The DRX3000 provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment consists of a physician prescribed treatment period on the DRX3000 and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves 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/K022602 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022602: DRX3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022602
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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