510(k) · Cleared
ClearedEscotek Est Trac 401
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nor-Am Patient Care Products, Inc. · ITH Equipment, Traction, Powered
Cleared on May 1, 1985 after a 169-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 27 later devices descend from it.
- Decided
- May 1, 1985
- Review
- 169 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 6 citing it directly.
- This deviceK844385 Escotek Est Trac 401Nor-Am Patient Care Products, Inc. · 1985
- Descendant · cites it directly · 16 of its ownK981822 DRS SystemProfessional Distribution Systems, Inc. · 1998
- Descendant · 2 generations on · 10 of its ownK030060 SpinemedCert Health Sciences, LLC · 2003
- Descendant · 2 generations on · 9 of its ownK031862 Spinerx-LDMSpinerx Technology · 2003
- Descendant · cites it directly · 9 of its ownK992733 Akron ATP9 Traction MachineHuntleigh Technology, Inc. · 1999
- Descendant · cites it directly · 8 of its ownK053223 Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K981822DRS SystemProfessional Distribution Systems, Inc. · 1998 · cites it directly16descendants
- K030060SpinemedCert Health Sciences, LLC · 2003 · 2 generations on10descendants
- K031862Spinerx-LDMSpinerx Technology · 2003 · 2 generations on9descendants
- K992733Akron ATP9 Traction MachineHuntleigh Technology, Inc. · 1999 · cites it directly9descendants
- K053223Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K844385 | Escotek Est Trac 401 | Nor-Am Patient Care Products, Inc. | 1985 | — |
| +1 | K981822 | DRS System | Professional Distribution Systems, Inc. | 1998 | — |
| +2 | K030060 | Spinemed | Cert Health Sciences, LLC | 2003 | — |
| +2 | K031862 | Spinerx-LDM | Spinerx Technology | 2003 | — |
| +1 | K992733 | Akron ATP9 Traction Machine | Huntleigh Technology, Inc. | 1999 | — |
| +1 | K053223 | Triton/Tru-Trac/TX/Triton DTS Traction | Chattanooga Group | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (27)
See all 276 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?
- Of its descendants, K981822 (Professional Distribution Systems, Inc., 1998) has gone furthest, with 16 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 | — |
https://510kreport.com/device/K844385 · printed Nov 4, 2026
Cite this page
510(k) Report. “K844385: Escotek Est Trac 401.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K844385
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026