510(k) · Cleared
ClearedSmart Adjuster (SA201)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigma · LXM Manipulator, Plunger-Like Joint
Cleared on Jan 10, 1997 as substantially equivalent to K940085 (Sense Technology, Inc., 1994) after a 213-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Jan 10, 1997
- Review
- 213 days
- Class
- Class U
- Product code
- LXM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940085 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK940085 Force Recording and Analysis System, Model 01Sense Technology, Inc. · 1994
- This deviceK962239 Smart Adjuster (SA201)Sigma · 1997
- Descendant · cites it directly · 0 of its ownK160278 VSTAAR AdjusteRSpinal Acoustics, LLC · 2016
- Descendant · cites it directly · 0 of its ownK050428 Technology-Assisted Micro-Mobilization and Reflex Stimulator (Tamars)Advanced Spinal Technologies, Inc. · 2005
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 |
|---|---|---|---|---|---|
| −1 | K940085 | Force Recording and Analysis System, Model 01 | Sense Technology, Inc. | 1994 | — |
| 0 (this device) | K962239 | Smart Adjuster (SA201) | Sigma | 1997 | — |
| +1 | K160278 | VSTAAR AdjusteR | Spinal Acoustics, LLC | 2016 | — |
| +1 | K050428 | Technology-Assisted Micro-Mobilization and Reflex Stimulator (Tamars) | Advanced Spinal Technologies, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K940085 | Force Recording and Analysis System, Model 01Summary page 1…Smart Adjuster Common Name: Chiropractic Adjusting Unit Classification name: Unclassified Equivalent Device: Force Recording and Adjusting System (FRAS). 510(k) Number K940085. Marketed by Sense Technology, Inc. Description of the Device: The Smart Adjuster is a device that is equivalent to the Force R… | 1994 |
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?
- Its one ancestor has no recall.
- Of its descendants, K160278 (Spinal Acoustics, LLC, 2016) 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.
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?
This device will be used by chiropractors to as an additional analysis tool to help identify areas of fixation and/or subluxation of the human spine. Additionally, it will allow the doctors to perform mechanical adjustments to the human spine.
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/K962239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962239: Smart Adjuster (SA201).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962239
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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