510(k) · Cleared
ClearedBass Antalgic-Trak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Traction Masters, LLC · ITH Equipment, Traction, Powered
Cleared on Mar 21, 2005 as substantially equivalent to K981822 (Professional Distribution Systems, Inc., 1998) and 4 other predicates after a 189-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Mar 21, 2005
- Review
- 189 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K894435 (1989). 7 ancestors in all, the oldest K844385 (1985). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894435 | Vax-T Pelvic Traction Belt | Vat-Tech, Inc. | 1989 | — |
| −2 | K951622 | Vax-D Therapeutic Table | Vat-Tech, Inc. | 1996 | — |
| −1 | K981822 | DRS System | Professional Distribution Systems, Inc. | 1998 | — |
| 0 (this device) | K042482 | Bass Antalgic-Trak | Traction Masters, LLC | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 2000 | 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? (5)
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 |
|---|---|---|---|
| * | K981822 | DRS SystemSummary page 1…tially Equivalent To: The Bass Antalgic-Trak is substantially equivalent to products currently in commercial distribution. These include the: 1) The DRS System (K98 1822) 2) The Tru-Trak Traction Table (K8893448) 3) The Vax-D Therapeutic Table (K95 1622) 4) The Saunders 3-D activetra… | 1998 |
| * | K893448 | Tru Trac Traction TableSummary page 1…substantially equivalent to products currently in commercial distribution. These include the: 1) The DRS System (K98 1822) 2) The Tru-Trak Traction Table (K8893448) 3) The Vax-D Therapeutic Table (K95 1622) 4) The Saunders 3-D activetrac (KO017 12) 5) TIhe Jilco Traction Flexi… | 1989 |
| * | K951622 | Vax-D Therapeutic TableSummary page 1…ly in commercial distribution. These include the: 1) The DRS System (K98 1822) 2) The Tru-Trak Traction Table (K8893448) 3) The Vax-D Therapeutic Table (K95 1622) 4) The Saunders 3-D activetrac (KO017 12) 5) TIhe Jilco Traction Flexion Chair (K001361)… | 1996 |
| * | K001712 | 3D Activetrac | 2000 |
| * | K001361 | Jilco Traction-Flexion ChairSummary page 1…-Trak Traction Table (K8893448) 3) The Vax-D Therapeutic Table (K95 1622) 4) The Saunders 3-D activetrac (KO017 12) 5) TIhe Jilco Traction Flexion Chair (K001361) W~cf-t TRACTION MASTE… | 2000 |
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 16 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- None of the 7 ancestors has a recall.
- 7 other devices also cite its predicate K981822.
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?
1) Patients with disc protrusions.
2) Patients with mild disc herniations.
3) Patients with pinched nerves.
4) Patients with limited spinal flexibility.
5) Patients with muscle spasms.
6) Patients with spinal vertebral fixations.
7) Patients with spinal facet imbrication and fixation.
8) Patients with spinal nerve root radiculitis.
9) Patients with foraminal encroachment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042482 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042482: Bass Antalgic-Trak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042482
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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