510(k) · Cleared
ClearedDynatron DX2 Traction Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynatronics Corp. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Oct 11, 2005 as substantially equivalent to K993919 (Dynatronics Corp., 2000) and 2 other predicates after a 110-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Oct 11, 2005
- Review
- 110 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K001179 (2000). 9 ancestors in all, the oldest K941461 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 2 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 1 generation backK031329 Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared…Dynatronics Corp. · 2003
- This deviceK051680 Dynatron DX2 Traction UnitDynatronics Corp. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −2 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −1 | K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe… | Dynatronics Corp. | 2003 | — |
| 0 (this device) | K051680 | Dynatron DX2 Traction Unit | Dynatronics Corp. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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 ILY? 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 ILY device
- #1 K242755 Medical Diode Laser Systems (VELAS II-30B…score 18.7 · 22 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 |
|---|---|---|---|
| * | K993919 | Dynatron 900Summary page 1…ass It Regulation Nos.: 890.5900; 890.5500 Product Codes: ITH, ILY 2. PREDICATE DEVICES: Dynatron 900 Traction Unit - cleared under K993919 Lordex Power Traction Unit - cleared under K031227 Dynatron 705 - cleared under K03 1329 3. PERFORMANCE STANDARDS… | 2000 |
| * | K031227 | Lordex Power Traction EquipmentSummary page 1…Product Codes: ITH, ILY 2. PREDICATE DEVICES: Dynatron 900 Traction Unit - cleared under K993919 Lordex Power Traction Unit - cleared under K031227 Dynatron 705 - cleared under K03 1329 3. PERFORMANCE STANDARDS: The Dynatron DX2 device conforms to the applicable re… | 2003 |
| * | K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional…Summary page 1…EDICATE DEVICES: Dynatron 900 Traction Unit - cleared under K993919 Lordex Power Traction Unit - cleared under K031227 Dynatron 705 - cleared under K03 1329 3. PERFORMANCE STANDARDS: The Dynatron DX2 device conforms to the applicable requirements of 21 CFR sections 1010 (Performan… | 2003 |
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 5 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K993919.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ILY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ILY
116in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ILY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILY
17in 2025
MAUDE reports naming product code ILY, 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 | 10 | 128 | 0 | 24 |
| 2008 | 16 | 165 | 0 | 20 |
| 2009 | 13 | 189 | 0 | 9 |
| 2010 | 8 | 185 | 1 | 7 |
| 2011 | 9 | 198 | 0 | 10 |
| 2012 | 11 | 130 | 3 | 7 |
| 2013 | 9 | 211 | 0 | 8 |
| 2014 | 11 | 153 | 0 | 0 |
| 2015 | 11 | 146 | 0 | 2 |
| 2016 | 8 | 214 | 0 | 2 |
| 2017 | 5 | 116 | 0 | 12 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 2 | — | 4 | 2 |
| 2023 | 1 | — | 1 | 15 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 1 | — | 1 | 17 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Dynatron DX2 is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It 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. The Dynatron DX2 also functions…
Read the full statement (130 words)
The Dynatron DX2 is designed to provide static, intermittent, and cycling distraction forces to
relieve pressures on structures that may be causing low back pain. It 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.
The Dynatron DX2 also functions as a system console for controlling the function of infrared
therapy devices such as the Dynatron D880 (K031329) and the Dynatron D890 (D040729).
Indications for use of these infrared therapy devices are to provide topical heating for
temporary increase in blood circulation, temporary relief of minor muscle and joint aches,
pains and stiffness, relaxation of muscles, muscle spasms, and minor pain and stiffness
associated with arthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051680 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051680: Dynatron DX2 Traction Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051680
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