510(k) · Cleared
Recalled · 2005TM-300 Traction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ito Co., Ltd. · ITH Equipment, Traction, Powered
Cleared on Sep 1, 1999 as substantially equivalent to K981822 (Professional Distribution Systems, Inc., 1998) after a 33-day review. Its family tree reaches back 3 generations to 1989. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 1, 1999
- Review
- 33 days
- Class
- Class II
- Product code
- ITH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K894435 (1989). 4 ancestors in all, the oldest K844385 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK894435 Vax-T Pelvic Traction BeltVat-Tech, Inc. · 1989
- 2 generations backK951622 Vax-D Therapeutic TableVat-Tech, Inc. · 1996
- 1 generation backK981822 DRS SystemProfessional Distribution Systems, Inc. · 1998
- This deviceK992545 TM-300 Traction SystemIto Co., Ltd. · 1999
- Descendant · cites it directly · 0 of its ownK091540 MTD 4000Mettler Electronics Corp. · 2009 · Recalled
- Descendant · cites it directly · 0 of its ownK081247 TM-400Ito Co., Ltd. · 2008
Most influential descendants
Showing 2 of 2 · See allView 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) | K992545 | TM-300 Traction System | Ito Co., Ltd. | 1999 | — |
| +1 | K091540 | MTD 4000 | Mettler Electronics Corp. | 2009 | 1 |
| +1 | K081247 | TM-400 | Ito Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K981822 | DRS SystemSummary page 1…The TM-300 Traction System is substantially equivalent to the DRS System manufactured by Professional Distribution Systems, lInc., which was cleared on June 24, 1998 as K981822. B. DEVICE DESCRIPTION The TM-300 Traction System is an automatic intermittent traction system for traction therapy. The patien… | 1998 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 13, 2005 | Not classified | Z-1444-05 | Other | The traction device may malfunction, producing oscillation and a jerking motion. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K091540 (Mettler Electronics Corp., 2009) has gone furthest, with 0 descendants of its own.
- 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?
The TM-300 Traction System is indicated for relief of pain in cases of low back pain. Each treatment consists of a physician-prescribed session designed to provide static, intermittent, or cycling distraction forces to relieve pressure on structures that may be causing low back pain. The TM-300 relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
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/K992545 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992545: TM-300 Traction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992545
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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