510(k) · Cleared
ClearedTraction System, Digit-Trac 930
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ever Prosperous Instrument, Inc. · ITH Equipment, Traction, Powered
Cleared on Jan 13, 2006 as substantially equivalent to K862846 (Therapeutic Equipment Corp., 1986) and 1 other predicate after a 128-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it.
- Decided
- Jan 13, 2006
- Review
- 128 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K862846 (1986). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK862846 Tec Vari-Trac II Traction UnitTherapeutic Equipment Corp. · 1986
- This deviceK052453 Traction System, Digit-Trac 930Ever Prosperous Instrument, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK112074 Everyway Traction Unit, Model Ever-Trac ET-800Everyway Medical Instruments Co.,Ltd · 2012
- Descendant · cites it directly · 0 of its ownK072064 Gravilax Traction SystemTherapeutic Clinical Technologies, Inc. · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862846 | Tec Vari-Trac II Traction Unit | Therapeutic Equipment Corp. | 1986 | — |
| 0 (this device) | K052453 | Traction System, Digit-Trac 930 | Ever Prosperous Instrument, Inc. | 2006 | — |
| +1 | K112074 | Everyway Traction Unit, Model Ever-Trac ET-800 | Everyway Medical Instruments Co.,Ltd | 2012 | — |
| +1 | K072064 | Gravilax Traction System | Therapeutic Clinical Technologies, Inc. | 2008 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K862846 | Tec Vari-Trac II Traction UnitSummary page 1…890.5900 * Proprietary name: TRACTION SYSTEM, DIGIT-TRAC 930 * Common name of device: POWERED TRACTION EQUIPMENT * Predicate Device: 1. K862846 TEC VARI-TRAC II TRACTION UNIT 2.K993919… | 1986 |
| * | K993919 | Dynatron 900Summary page 1…POWERED TRACTION EQUIPMENT * Predicate Device: 1. K862846 TEC VARI-TRAC II TRACTION UNIT 2.K993919 DYNATRON 900 P5 Statement of Intended… | 2000 |
What descends from it? (2)
2 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 TRACTION SYSTEM, DIGIT-TRAC 930 is intended for medical purpose for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052453 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052453: Traction System, Digit-Trac 930.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052453
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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