510(k) · Cleared
Recalled · 2008Cycletrac CT-5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pt Products, LLC · ITH Equipment, Traction, Powered
Cleared on Feb 14, 2008 as substantially equivalent to K053223 (Chattanooga Group, 2006) and 2 other predicates after a 59-day review. Its family tree reaches back 5 generations to 1989. It has been recalled 2 times.
- Decided
- Feb 14, 2008
- Review
- 59 days
- Class
- Class II
- Product code
- ITH
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 5 generations to K894435 (1989). 20 ancestors in all, the oldest K834405 (1984). No later device cites it as a predicate yet.
- Root · 5 generations backK894435 Vax-T Pelvic Traction BeltVat-Tech, Inc. · 1989
- 4 generations backK951622 Vax-D Therapeutic TableVat-Tech, Inc. · 1996
- 3 generations backK981822 DRS SystemProfessional Distribution Systems, Inc. · 1998
- 2 generations backK030060 SpinemedCert Health Sciences, LLC · 2003
- 1 generation backK053223 Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006
- This deviceK073542 Cycletrac CT-5000Pt Products, LLC · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894435 | Vax-T Pelvic Traction Belt | Vat-Tech, Inc. | 1989 | — |
| −4 | K951622 | Vax-D Therapeutic Table | Vat-Tech, Inc. | 1996 | — |
| −3 | K981822 | DRS System | Professional Distribution Systems, Inc. | 1998 | — |
| −2 | K030060 | Spinemed | Cert Health Sciences, LLC | 2003 | — |
| −1 | K053223 | Triton/Tru-Trac/TX/Triton DTS Traction | Chattanooga Group | 2006 | — |
| 0 (this device) | K073542 | Cycletrac CT-5000 | Pt Products, LLC | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 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 |
|---|---|---|---|
| * | K053223 | Triton/Tru-Trac/TX/Triton DTS TractionSummary page 1…ision of Encore Medical, L.P. Regulatory Class: II Product Code: ITH 510K Number: K053223 Approved February 24, 2006 3D ActiveTrac Hi-Lo Traction Table (Headrest)… | 2006 |
| * | K001712 | 3D ActivetracSummary page 1…The Saunders Group, Inc. Regulatory Class: II Product Code: ITH 510K Number: K001712 Approved August 31, 2000 DRS System Professional Dist… | 2000 |
| * | K981822 | DRS SystemSummary page 1…Distribution Systems, Inc. Regulatory Class: II Product Code: ITH 510K Number: K981822 Approved June 24, 1998 Device Description: The CycleTrac® CT-5000 Automated Cervical Traction Unit… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 29, 2008 | Not classified | Z-0341-2009 | Device Design | Under certain conditions, x-ray system may experience operational impairment. |
| Aug 29, 2008 | Not classified | Z-0342-2009 | Device Design | Under certain conditions, x-ray system may experience operational impairment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- None of the 20 ancestors has a recall.
- 6 other devices also cite its predicate K053223.
How does its category compare?
All ITH devicesITH Equipment, Traction, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 CycleTrac® Automated Cervical Traction Unit provides a primary
treatment modality for the management of neck and back pain.
Intermittent/static cervical traction results in cervical disk decompression
(unloading due to distraction and positioning) which provides relief of
pain associated with a variety of conditions involving anatomical
dysfunctions of the spine, including protruding or herniated intervertebral
discs, degenerative discs and acute facet problems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073542 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073542: Cycletrac CT-5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073542
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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