510(k) · Cleared
ClearedImpulse-Adjusting Instrument, CBP Adjusting Instrument, Neuromechanical Adjusting Instrument, Models 2003
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuromechanical Innovations, LLC · LXM Manipulator, Plunger-Like Joint
Cleared on Jan 13, 2003 as substantially equivalent to K010851 (Harrison Cbp Seminars, 2001) and 4 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1994. 5 later devices descend from it.
- Decided
- Jan 13, 2003
- Review
- 90 days
- Class
- Class U
- Product code
- LXM
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K930431 (1994). 6 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK930431 Arthrostim ManipulatorFreeman Procedure Seminars · 1994
- 1 generation backK973506 Activator IIActivator Methods, Inc. · 1998
- This deviceK023462 Impulse-Adjusting Instrument, CBP Adjusting Instrument…Neuromechanical Innovations, LLC · 2003
- Descendant · cites it directly · 2 of its ownK080261 Impulse IQ Adjusting InstrumentNeuromechanical Innovations, LLC · 2008
- Descendant · cites it directly · 1 of its ownK072519 Activator V Spinal Adjusting InstrumentActivator Methods International, Ltd. · 2007
- Descendant · 2 generations on · 0 of its ownK160278 VSTAAR AdjusteRSpinal Acoustics, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK082218 Max Adjusting InstrumentManna Omni International, Inc. · 2008
- 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 5 of 5 · See all- K080261Impulse IQ Adjusting InstrumentNeuromechanical Innovations, LLC · 2008 · cites it directly2descendants
- K072519Activator V Spinal Adjusting InstrumentActivator Methods International, Ltd. · 2007 · cites it directly1descendant
- K160278VSTAAR AdjusteRSpinal Acoustics, LLC · 2016 · 2 generations on0descendants
- K082218Max Adjusting InstrumentManna Omni International, Inc. · 2008 · 2 generations on0descendants
- K050428Technology-Assisted Micro-Mobilization and Reflex Stimulator (Tamars)Advanced Spinal Technologies, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930431 | Arthrostim Manipulator | Freeman Procedure Seminars | 1994 | — |
| −1 | K973506 | Activator II | Activator Methods, Inc. | 1998 | — |
| 0 (this device) | K023462 | Impulse-Adjusting Instrument, CBP Adjusting Instrument, Neuromechanical… | Neuromechanical Innovations, LLC | 2003 | — |
| +1 | K080261 | Impulse IQ Adjusting Instrument | Neuromechanical Innovations, LLC | 2008 | — |
| +1 | K072519 | Activator V Spinal Adjusting Instrument | Activator Methods International, Ltd. | 2007 | — |
| +2 | K160278 | VSTAAR AdjusteR | Spinal Acoustics, LLC | 2016 | — |
| +2 | K082218 | Max Adjusting Instrument | Manna Omni International, Inc. | 2008 | — |
| +1 | K050428 | Technology-Assisted Micro-Mobilization and Reflex Stimulator (Tamars) | Advanced Spinal Technologies, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K010851 | Harrison Hand Held Adjusting Instrument | 2001 |
| * | K001476 | Torque Instrument, Model 8500 | 2000 |
| * | K930431 | Arthrostim ManipulatorSummary page 1…KO10851 - Harrison Hand Held Adjusting Instrument Substantial Equivalence : KO0 1476 - Torque Specific Cervical Adjusting Instrument K93043 1 - Arthrostim KO03 185 - Full Spectrum Activator 111 K973506 - Activator I… | 1994 |
| * | K003185 | FS Activator Iii | 2001 |
| * | K973506 | Activator IISummary page 1…cal Adjusting Instrument K93043 1 - Arthrostim KO03 185 - Full Spectrum Activator 111 K973506 - Activator I1 Adjusting Instrument Establishment Applied for herein. Registration #: Classification:… | 1998 |
What descends from it? (5)
3 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 9 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K080261 (Neuromechanical Innovations, LLC, 2008) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K010851.
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?
ImpulseTM (aka NeuromechanicalTM, aka CBP') Adjusting Instrument is for adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine and/or extremities by a licensed health care professional. The device is for external use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023462: Impulse-Adjusting Instrument, CBP Adjusting Instrument, Neuromechanical Adjusting Instrument, Models 2003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023462
Report an extraction error
Are you the manufacturer?
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