510(k) · Cleared
Recalled · Class II · 2024Decompression of Choice and Neuro Decompression Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pivotal Health Solutions · ITH Equipment, Traction, Powered
Cleared on Aug 27, 2010 as substantially equivalent to K001712 (The Saunders Group, 2000) and 1 other predicate after a 51-day review. Its family tree reaches back 5 generations to 1989. It has been recalled once.
- Decided
- Aug 27, 2010
- Review
- 51 days
- Class
- Class II
- Product code
- ITH
- Recalls
- 1
- Predicates
- 2
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 deviceK101889 Decompression of Choice and Neuro Decompression DevicePivotal Health Solutions · 2010
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) | K101889 | Decompression of Choice and Neuro Decompression Device | Pivotal Health Solutions | 2010 | — |
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? (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 |
|---|---|---|---|
| * | K001712 | 3D ActivetracSummary page 2…5Page 2of 4 Revision E *PWO(TA 6- Technological Characteristics Comparison Summary The Devices and predicate device K001712 are similar in shape and can be divided into similar smaller sections. They have a base, elevation, cervical, thoracic, pelvic… | 2000 |
| * | K053223 | Triton/Tru-Trac/TX/Triton DTS TractionSummary page 1…formation: The Devices are substantially equivalent to the Saunders Group 3D Active Trac. K(001 712 and Chattanooga Group Triton/Tru-Trac/Tx/Triton Dts Traction K053223. 4. Device Description: The Devices are a non surgical fraction or also called decompression1 systems. It accurately control… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 29, 2024 | Class II | Z-2326-2024 | Nonconforming Material/Component | This product is being recalled due to potentially insufficient rework on a part (E7130-B) on the lumbar section of the frame on 6 distributed tables. There were 4 additional tables with the faulty E7130-B part that were manufactured, but… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- None of the 20 ancestors has a recall.
- 6 other devices also cite its predicate K001712.
How does its category compare?
All ITH devicesITH Equipment, Traction, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Decompression' of Choice (DOG) and MAAR 2K10 is a non invasive method of applying distractive forces to the spine through controlled tensions.
It is designed to apply decompression (decompression is unloading due to distraction and positioning and/or as non-surgical in nature) forces to intervertebrall discs.
The Decompression' of Choice (DOC) and AAAR 2K1 0 may be used for back pain, neck pain, herniated discs, protruding discs, degenerative disc disease, sciatica and posterior facet syndromes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101889: Decompression of Choice and Neuro Decompression Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101889
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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