510(k) · Cleared
ClearedEveryway Traction Unit, Model Ever-Trac ET-800
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Everyway Medical Instruments Co.,Ltd · ITH Equipment, Traction, Powered
Cleared on Feb 1, 2012 as substantially equivalent to K052453 (Ever Prosperous Instrument, Inc., 2006) after a 196-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Feb 1, 2012
- Review
- 196 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K862846 (1986). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK862846 Tec Vari-Trac II Traction UnitTherapeutic Equipment Corp. · 1986
- 1 generation backK052453 Traction System, Digit-Trac 930Ever Prosperous Instrument, Inc. · 2006
- This deviceK112074 Everyway Traction Unit, Model Ever-Trac ET-800Everyway Medical Instruments Co.,Ltd · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K862846 | Tec Vari-Trac II Traction Unit | Therapeutic Equipment Corp. | 1986 | — |
| −1 | K052453 | Traction System, Digit-Trac 930 | Ever Prosperous Instrument, Inc. | 2006 | — |
| 0 (this device) | K112074 | Everyway Traction Unit, Model Ever-Trac ET-800 | Everyway Medical Instruments Co.,Ltd | 2012 | — |
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 |
|---|---|---|---|
| * | K052453 | Traction System, Digit-Trac 930Summary page 1…Everyway Traction Unit, model EVER-TRAC ET-800. 3. Information of the 510(k) Cleared Device (Predicate Device): Ever Prosperous Traction System model DIGIT-TRAC 930(K052453) 4. Classification Information: Trade/Device Name: Everyway Traction Unit, model EVER-TRAC ET-800. Regulation Number: 21 C… | 2006 |
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 26 years and passes through 3 companies; a new generation was cleared every 19.4 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K052453.
How does its category compare?
All ITH devicesITH Equipment, Traction, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Everyway Traction System, model EVER-TRAC ET-800 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/K112074 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112074: Everyway Traction Unit, Model Ever-Trac ET-800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112074
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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