510(k) · Cleared
ClearedVax-T Pelvic Traction Belt
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 Aug 3, 1989 after a 14-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
- Aug 3, 1989
- Review
- 14 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 1 citing it directly.
- This deviceK894435 Vax-T Pelvic Traction BeltVat-Tech, Inc. · 1989
- Descendant · cites it directly · 26 of its ownK951622 Vax-D Therapeutic TableVat-Tech, Inc. · 1996
- Descendant · 2 generations on · 16 of its ownK053503 Vax-D Genesis System (Therapeutic Table)Vax-D Medical Technologies USA, L.C. · 2005
- Descendant · 2 generations on · 16 of its ownK981822 DRS SystemProfessional Distribution Systems, Inc. · 1998
- Descendant · 3 generations on · 10 of its ownK030060 SpinemedCert Health Sciences, LLC · 2003
- Descendant · 2 generations on · 9 of its ownK031862 Spinerx-LDMSpinerx Technology · 2003
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K951622Vax-D Therapeutic TableVat-Tech, Inc. · 1996 · cites it directly26descendants
- K053503Vax-D Genesis System (Therapeutic Table)Vax-D Medical Technologies USA, L.C. · 2005 · 2 generations on16descendants
- K981822DRS SystemProfessional Distribution Systems, Inc. · 1998 · 2 generations on16descendants
- K030060SpinemedCert Health Sciences, LLC · 2003 · 3 generations on10descendants
- K031862Spinerx-LDMSpinerx Technology · 2003 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894435 | Vax-T Pelvic Traction Belt | Vat-Tech, Inc. | 1989 | — |
| +1 | K951622 | Vax-D Therapeutic Table | Vat-Tech, Inc. | 1996 | — |
| +2 | K053503 | Vax-D Genesis System (Therapeutic Table) | Vax-D Medical Technologies USA, L.C. | 2005 | — |
| +2 | K981822 | DRS System | Professional Distribution Systems, Inc. | 1998 | — |
| +3 | K030060 | Spinemed | Cert Health Sciences, LLC | 2003 | — |
| +2 | K031862 | Spinerx-LDM | Spinerx Technology | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 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), 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 271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K951622 | Vax-D Therapeutic Table | 1996 | 26 |
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, K951622 (Vat-Tech, Inc., 1996) has gone furthest, with 26 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/K894435 · printed Nov 6, 2026
Cite this page
510(k) Report. “K894435: Vax-T Pelvic Traction Belt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K894435
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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