510(k) · Cleared
ClearedKhan Kinetic Treatment Device (KKT-M1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optima Health Solutions International, Inc. · LXM Manipulator, Plunger-Like Joint
Cleared on Mar 23, 2006 as substantially equivalent to K951217 (Sweat Chiropractic Clinic, 1995) after a 76-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- Mar 23, 2006
- Review
- 76 days
- Class
- Class U
- Product code
- LXM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951217 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK951217 Atlas Orthogonal Percussion InsttumentSweat Chiropractic Clinic · 1995
- This deviceK060043 Khan Kinetic Treatment Device (KKT-M1)Optima Health Solutions International, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK130666 Khan Kinetic Treatment (KKT-M2)Optima Health Solutions International Corporation · 2014
- Descendant · 2 generations on · 0 of its ownK234036 Sonik Monark 100Neuro Spinal Innovation, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK192629 SpinalyticsOptima Health Solutions International Corp. · 2019
Most influential descendants
Showing 3 of 3 · See all- K130666Khan Kinetic Treatment (KKT-M2)Optima Health Solutions International Corporation · 2014 · cites it directly2descendants
- K234036Sonik Monark 100Neuro Spinal Innovation, Inc. · 2024 · 2 generations on0descendants
- K192629SpinalyticsOptima Health Solutions International Corp. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951217 | Atlas Orthogonal Percussion Insttument | Sweat Chiropractic Clinic | 1995 | — |
| 0 (this device) | K060043 | Khan Kinetic Treatment Device (KKT-M1) | Optima Health Solutions International, Inc. | 2006 | — |
| +1 | K130666 | Khan Kinetic Treatment (KKT-M2) | Optima Health Solutions International Corporation | 2014 | — |
| +2 | K234036 | Sonik Monark 100 | Neuro Spinal Innovation, Inc. | 2024 | — |
| +2 | K192629 | Spinalytics | Optima Health Solutions International Corp. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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 7.5 · 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 |
|---|---|---|---|
| * | K951217 | Atlas Orthogonal Percussion InsttumentSummary page 1…Name: The Atlas Orthogonal Percussion Instrument Classification Product Code: LXM 510(k) Number: K951217 Marketed by: Sweat Chiropractic Clinic Address: 3274 Buckeye Rd. N.E,… | 1995 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130666 | Khan Kinetic Treatment (KKT-M2) | 2014 | 2 |
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?
- Its one ancestor has no recall.
- Of its descendants, K130666 (Optima Health Solutions International Corporation, 2014) has gone furthest, with 2 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.
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 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 device is to be used for the treatment of vertebral motor units which appear to be fixated. The procedure can involve x-ray analysis that quantifies the lateral and rotational misalignments between the vertebrae. The treatment is then administered using the KKT device to deliver precise impulses at a required vector configuration.
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/K060043 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060043: Khan Kinetic Treatment Device (KKT-M1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060043
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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