510(k) · Cleared
ClearedKhan Kinetic Treatment (KKT-M2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optima Health Solutions International Corporation · LXM Manipulator, Plunger-Like Joint
Cleared on Jan 23, 2014 as substantially equivalent to K060043 (Optima Health Solutions International, Inc., 2006) after a 317-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Jan 23, 2014
- Review
- 317 days
- Class
- Class U
- Product code
- LXM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K951217 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK951217 Atlas Orthogonal Percussion InsttumentSweat Chiropractic Clinic · 1995
- 1 generation backK060043 Khan Kinetic Treatment Device (KKT-M1)Optima Health Solutions International, Inc. · 2006
- This deviceK130666 Khan Kinetic Treatment (KKT-M2)Optima Health Solutions International Corporation · 2014
- Descendant · cites it directly · 0 of its ownK234036 Sonik Monark 100Neuro Spinal Innovation, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK192629 SpinalyticsOptima Health Solutions International Corp. · 2019
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 |
|---|---|---|---|---|---|
| −2 | K951217 | Atlas Orthogonal Percussion Insttument | Sweat Chiropractic Clinic | 1995 | — |
| −1 | K060043 | Khan Kinetic Treatment Device (KKT-M1) | Optima Health Solutions International, Inc. | 2006 | — |
| 0 (this device) | K130666 | Khan Kinetic Treatment (KKT-M2) | Optima Health Solutions International Corporation | 2014 | — |
| +1 | K234036 | Sonik Monark 100 | Neuro Spinal Innovation, Inc. | 2024 | — |
| +1 | K192629 | Spinalytics | Optima Health Solutions International Corp. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 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 LXM? 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 LXM device
- #1 K234036 Sonik Monark 100score 7.4 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K060043 | Khan Kinetic Treatment Device (KKT-M1)Summary page 1…vice: Name:........................ Khan Kinetic Treatment Device (KKT-M1) Product Code: ............... LXM 510(k) Number: .............. K060043 Marketed by: ............. Optima Health Solutions International Corp. Address: .....................… | 2006 |
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)
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 19 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K234036 (Neuro Spinal Innovation, Inc., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LXM devicesLXM Manipulator, Plunger-Like Joint: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LXM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LXM
Too few LXM 510(k)s in any year since 2007 to give a median.
Recalls per year · LXM
No recall names LXM since 2007.
Adverse event reports per year · LXM
1in 2020
MAUDE reports naming product code LXM, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The KKT-M2 device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the total care of the patient. The procedure involves the use of diagnostic imaging that qualifies the misalignment between vertebrae. The treatment is then administered using the KKT-M2 device to deliver precise impulses at a required vector configuration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130666: Khan Kinetic Treatment (KKT-M2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130666
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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