510(k) · Cleared
ClearedDRX9000C-SL Cervical Spinal Decompression System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Excite Medical of Tampa Bay, LLC · ITH Equipment, Traction, Powered
Cleared on Jun 18, 2025 as substantially equivalent to K023160 (Axiom Usa., Inc., 2002) after a 233-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Jun 18, 2025
- Review
- 233 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K844385 (1985). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K844385 | Escotek Est Trac 401 | Nor-Am Patient Care Products, Inc. | 1985 | — |
| −1 | K023160 | DRX5000 | Axiom Usa., Inc. | 2002 | — |
| 0 (this device) | K243366 | DRX9000C-SL Cervical Spinal Decompression System | Excite Medical of Tampa Bay, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (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 |
|---|---|---|---|
| * | K023160 | DRX5000Summary page 5…TE / LEGALLY MARKETED DEVICES Device Name: DRX5000 Company Name: Axiom USA, Inc. (a.k.a. Axiom Worldwide, Inc.) 510(k) #: K023160 Page 1 of 6 D. DEVICE DESCRIPTION The DRX9000C-SL Cervical Spinal Decomp… | 2002 |
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 40 years and passes through 3 companies; a new generation was cleared every 22.5 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K023160.
How does its category compare?
All ITH devicesITH Equipment, Traction, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 DRX9000C-SL Cervical Spinal Decompression System provides a program of treatments for relief from pain for those patients suffering with neck pain. It is designed to apply spinal decompressive forces to the spine. Conditions that may be treated include neck pain associated with herniated discs, protruding intervertebral discs, degenerative disc disease, and posterior facet syndrome.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243366: DRX9000C-SL Cervical Spinal Decompression System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243366
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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