510(k) · Cleared
Recalled · 2011MTD 4000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mettler Electronics Corp. · ITH Equipment, Traction, Powered
Cleared on Oct 8, 2009 as substantially equivalent to K053223 (Chattanooga Group, 2006) and 2 other predicates after a 135-day review. Its family tree reaches back 5 generations to 1989. It has been recalled once.
- Decided
- Oct 8, 2009
- Review
- 135 days
- Class
- Class II
- Product code
- ITH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K894435 (1989). 21 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 deviceK091540 MTD 4000Mettler Electronics Corp. · 2009
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) | K091540 | MTD 4000 | Mettler Electronics Corp. | 2009 | — |
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 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K053223 | Triton/Tru-Trac/TX/Triton DTS TractionSummary page 1…NAME: Powered Traction Device Predicate Devices: a. TRADE NAME: Triton/Tru-Trac/TX/Triton DTS Traction Device by Chattanooga. b. 510(k)Number: K053223 c. TRADE NAME: TM-300 by ITO Co., Ltd. d. 510(k) Number: K992545 Description of Proposed Device: The MTD 4000 (… | 2006 |
| * | K992545 | TM-300 Traction SystemSummary page 1…/Tru-Trac/TX/Triton DTS Traction Device by Chattanooga. b. 510(k)Number: K053223 c. TRADE NAME: TM-300 by ITO Co., Ltd. d. 510(k) Number: K992545 Description of Proposed Device: The MTD 4000 (Mettler Traction Decompression) system is an easy to use device that offers stati… | 1999 |
| * | K051938 | Triton/Tru-Trac/TX Traction DevicesSummary page 3…TX Traction Distributor / Mettler Electronics Chattanooga Group Ito Co., Ltd. Manufacturer 510k K051938 K992545 Mains Supply AC 110-120 / 100-240V / 50/60 AC 110-120/220-240 220… | 2005 |
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 14, 2011 | Not classified | Z-2580-2011 | Device Design | The recall was initiated because Mettler has confirmed the possible failure of internal mechanical component and software detection for potential failure regarding Electronics Traction Device - MTD4000. The firm are initiating the recall… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 21 ancestors has a recall of any class.
- 6 other devices also cite its predicate K053223.
How does its category compare?
All ITH devicesITH Equipment, Traction, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 MTD 4000 traction device provides traction and mobilization of skeletal
structures and skeletal muscles.
The MTD 4000 may be used to relieve peripheral radiation/sciatica and pain
associated with:
Protruding discs
Bulging discs
Herniated discs
Degenerative disc disease
Posterior facet syndrome
Acute facet problems
Radicular pain
Prolapsed discs
Spinal root impingement
Hypomobility
Degenerative joint disease
Facet syndrome
Compressions fractures
Joint pain
EDiscogenic pain
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091540 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091540: MTD 4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091540
Report an extraction error
Are you the manufacturer?
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