510(k) · Cleared
ClearedVSTAAR AdjusteR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Acoustics, LLC · LXM Manipulator, Plunger-Like Joint
Cleared on Nov 4, 2016 as substantially equivalent to K962239 (Sigma, 1997) and 2 other predicates after a 276-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Nov 4, 2016
- Review
- 276 days
- Class
- Class U
- Product code
- LXM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K930431 (1994). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK930431 Arthrostim ManipulatorFreeman Procedure Seminars · 1994
- 3 generations backK973506 Activator IIActivator Methods, Inc. · 1998
- 2 generations backK023462 Impulse-Adjusting Instrument, CBP Adjusting Instrument…Neuromechanical Innovations, LLC · 2003
- 1 generation backK080261 Impulse IQ Adjusting InstrumentNeuromechanical Innovations, LLC · 2008
- This deviceK160278 VSTAAR AdjusteRSpinal Acoustics, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930431 | Arthrostim Manipulator | Freeman Procedure Seminars | 1994 | — |
| −3 | K973506 | Activator II | Activator Methods, Inc. | 1998 | — |
| −2 | K023462 | Impulse-Adjusting Instrument, CBP Adjusting Instrument, Neuromechanical… | Neuromechanical Innovations, LLC | 2003 | — |
| −1 | K080261 | Impulse IQ Adjusting Instrument | Neuromechanical Innovations, LLC | 2008 | — |
| 0 (this device) | K160278 | VSTAAR AdjusteR | Spinal Acoustics, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 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? (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 |
|---|---|---|---|
| * | K962239 | Smart Adjuster (SA201)Summary page 4…PREDICATE DEVICE – as required by 807.92(a)(3) One of the identified legally marketed predicate devices identified by the submitter is Smart Adjuster, K962239, submitted by Sigma Company [now known as Sigma Instruments]. A second legally marketed predicate device is… | 1997 |
| * | K973914 | Sense Technology Inc. Fras, Sense Technology Inc. PulstarSummary page 4…is Smart Adjuster, K962239, submitted by Sigma Company [now known as Sigma Instruments]. A second legally marketed predicate device is PulStarFRAS, K973914, submitted by Sense Technology. A third predicate device is the legally marketed Impulse IQ Adjusting Instrument, K08… | 1998 |
| * | K080261 | Impulse IQ Adjusting InstrumentSummary page 4…ed predicate device is PulStarFRAS, K973914, submitted by Sense Technology. A third predicate device is the legally marketed Impulse IQ Adjusting Instrument, K080261, submitted by Neuromechanical Innovations, LLC. B. SUMMARY DEVICE DESCRIPTION – as required by 807.92(a)(4) The… | 2008 |
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 22 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K962239.
How does its category compare?
All LXM devicesLXM Manipulator, Plunger-Like Joint: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 VSTAAR is a mechanical device intended to be used by chiropractors, medical doctors and other licensed health care professions for the external analysis and adjustment of the human spinal column, and for soft tissue musculoskeletal mobilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160278 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160278: VSTAAR AdjusteR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160278
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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