510(k) · Cleared
ClearedSpinalytics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optima Health Solutions International Corp. · LXM Manipulator, Plunger-Like Joint
Cleared on Dec 21, 2019 as substantially equivalent to K130666 (Optima Health Solutions International Corporation, 2014) after an 89-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Dec 21, 2019
- Review
- 89 days
- Class
- Class U
- Product code
- LXM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K951217 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK951217 Atlas Orthogonal Percussion InsttumentSweat Chiropractic Clinic · 1995
- 2 generations backK060043 Khan Kinetic Treatment Device (KKT-M1)Optima Health Solutions International, Inc. · 2006
- 1 generation backK130666 Khan Kinetic Treatment (KKT-M2)Optima Health Solutions International Corporation · 2014
- This deviceK192629 SpinalyticsOptima Health Solutions International Corp. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951217 | Atlas Orthogonal Percussion Insttument | Sweat Chiropractic Clinic | 1995 | — |
| −2 | 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 | — |
| 0 (this device) | K192629 | Spinalytics | Optima Health Solutions International Corp. | 2019 | — |
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 |
|---|---|---|---|
| * | K130666 | Khan Kinetic Treatment (KKT-M2)Summary page 5…LXM Device Class: Unclassified Classification Panel: Physical Medicine 5. Legally Marketed Predicate Device(s) KKT Device, Optima (K130666), primary predicate device EOS Imaging, sterEOS Workstation, (K141137); reference device 6. Device Description KKT Devic… | 2014 |
| † | K141137 | Stereos Workstation | 2014 |
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 24 years and passes through 4 companies; a new generation was cleared every 7.8 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K130666.
How does its category compare?
All LXM devicesLXM Manipulator, Plunger-Like Joint: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 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 quantifies the misalignment of vertebrae. The treatment is then administered using the KKT device to deliver impulses at a precise vector. Spinalytics is a software application which facilitates treatment using…
Read the full statement (160 words)
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 procedure involves the use of diagnostic imaging that quantifies the misalignment of vertebrae. The treatment is then administered using the KKT device to deliver impulses at a precise vector. Spinalytics is a software application which facilitates treatment using the KKT device.
Spinalytics provides an interface to manage the patient information stored in a central database. Spinalytics facilitates measuring angles and distances of relevant skeletal structures in a patient, by providing the practitioner with an interface to mark the position of these structures directly on digitized X-Rays. Spinalytics then calculates standard treatment protocol parameters which can be sent directly to the KKT device. Spinalytics is an optional accessory to the KKT device and does not change the intended use of the device.
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/K192629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192629: Spinalytics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192629
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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