510(k) · Cleared
ClearedVax-D Therapeutic Table
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vat-Tech, Inc. · ITH Equipment, Traction, Powered
Cleared on Jul 2, 1996 as substantially equivalent to K894435 (Vat-Tech, Inc., 1989) after a 488-day review. Its family tree reaches back 1 generation to 1989. 26 later devices descend from it.
- Decided
- Jul 2, 1996
- Review
- 488 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K894435 (1989). 26 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK894435 Vax-T Pelvic Traction BeltVat-Tech, Inc. · 1989
- This deviceK951622 Vax-D Therapeutic TableVat-Tech, Inc. · 1996
- Descendant · cites it directly · 16 of its ownK053503 Vax-D Genesis System (Therapeutic Table)Vax-D Medical Technologies USA, L.C. · 2005
- 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 · cites it directly · 9 of its ownK031862 Spinerx-LDMSpinerx Technology · 2003
- Descendant · 2 generations on · 8 of its ownK053223 Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K053503Vax-D Genesis System (Therapeutic Table)Vax-D Medical Technologies USA, L.C. · 2005 · cites it directly16descendants
- K981822DRS SystemProfessional Distribution Systems, Inc. · 1998 · cites it directly16descendants
- K030060SpinemedCert Health Sciences, LLC · 2003 · 2 generations on10descendants
- K031862Spinerx-LDMSpinerx Technology · 2003 · cites it directly9descendants
- K053223Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894435 | Vax-T Pelvic Traction Belt | Vat-Tech, Inc. | 1989 | — |
| 0 (this device) | K951622 | Vax-D Therapeutic Table | Vat-Tech, Inc. | 1996 | — |
| +1 | K053503 | Vax-D Genesis System (Therapeutic Table) | Vax-D Medical Technologies USA, L.C. | 2005 | — |
| +1 | K981822 | DRS System | Professional Distribution Systems, Inc. | 1998 | — |
| +2 | K030060 | Spinemed | Cert Health Sciences, LLC | 2003 | — |
| +1 | K031862 | Spinerx-LDM | Spinerx Technology | 2003 | — |
| +2 | 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 |
| 2003 | 3 | 0 |
| 2004 | 2 | 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 | 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 |
|---|---|---|---|
| * | K894435 | Vax-T Pelvic Traction BeltSummary page 2…orida 34684 Vi ThCHnc Telephone: 1-800-558-VAXD ¢ (813) 934-1002 ¢ Fax: (813) 943-9899 10. PREDICATE DEVICE: VAX-D® (or “VAX-T® ”) Therapeutic Table (K894435) DEVICE DESCRIPTION The VAX-D® Therapeutic Table is designed to apply distraction tensions to the patient’s lumbar spine. The p… | 1989 |
What descends from it? (26)
See all 268 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?
- Its one ancestor has no recall.
- Of its descendants, K053503 (Vax-D Medical Technologies USA, L.C., 2005) 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 | — |
What is it indicated for?
This therapy provides a primary treatment modality for the management of pain and disability for patients presenting with incapacitating low back pain. It has been found to provide relief in a variety of conditions involving anatomical dysfunctions of the lumbar spine that generate localized low back pain as well as peripheral radiation, including patients with protruding or herniated intervertebral discs, degenerative discs as well as those with acute facet problems.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K951622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951622: Vax-D Therapeutic Table.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951622
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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