510(k) · Cleared
ClearedImpulse IQ Adjusting Instrument
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 Apr 11, 2008 as substantially equivalent to K023462 (Neuromechanical Innovations, LLC, 2003) and 4 other predicates after a 70-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Apr 11, 2008
- Review
- 70 days
- Class
- Class U
- Product code
- LXM
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K930431 (1994). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK930431 Arthrostim ManipulatorFreeman Procedure Seminars · 1994
- 2 generations backK973506 Activator IIActivator Methods, Inc. · 1998
- 1 generation backK023462 Impulse-Adjusting Instrument, CBP Adjusting Instrument…Neuromechanical Innovations, LLC · 2003
- This deviceK080261 Impulse IQ Adjusting InstrumentNeuromechanical Innovations, LLC · 2008
- Descendant · cites it directly · 0 of its ownK160278 VSTAAR AdjusteRSpinal Acoustics, LLC · 2016
- Descendant · cites it directly · 0 of its ownK082218 Max Adjusting InstrumentManna Omni International, Inc. · 2008
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 |
|---|---|---|---|---|---|
| −3 | K930431 | Arthrostim Manipulator | Freeman Procedure Seminars | 1994 | — |
| −2 | K973506 | Activator II | Activator Methods, Inc. | 1998 | — |
| −1 | K023462 | Impulse-Adjusting Instrument, CBP Adjusting Instrument, Neuromechanical… | Neuromechanical Innovations, LLC | 2003 | — |
| 0 (this device) | K080261 | Impulse IQ Adjusting Instrument | Neuromechanical Innovations, LLC | 2008 | — |
| +1 | K160278 | VSTAAR AdjusteR | Spinal Acoustics, LLC | 2016 | — |
| +1 | K082218 | Max Adjusting Instrument | Manna Omni International, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 7.5 · 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 |
|---|---|---|---|
| * | K023462 | Impulse-Adjusting Instrument, CBP Adjusting Instrument, Neuromechanical Adjusting…Summary page 1…Instrument Product Code: LXM Classification Name: Manipulator, Plunger-like Joint Classification: Unclassified Predicate Devices for K023462 Impulse Adjusting Instrument Substantial Equivalence: K930431 Arthrostim Manipulator K… | 2003 |
| * | K930431 | Arthrostim ManipulatorSummary page 1…Manipulator, Plunger-like Joint Classification: Unclassified Predicate Devices for K023462 Impulse Adjusting Instrument Substantial Equivalence: K930431 Arthrostim Manipulator K973914 FRAS, Sense Technology, Inc. K… | 1994 |
| * | K973914 | Sense Technology Inc. Fras, Sense Technology Inc. PulstarSummary page 1…ssified Predicate Devices for K023462 Impulse Adjusting Instrument Substantial Equivalence: K930431 Arthrostim Manipulator K973914 FRAS, Sense Technology, Inc. K003185 Full Spectrum Activator III… | 1998 |
| * | K003185 | FS Activator IiiSummary page 1…strument Substantial Equivalence: K930431 Arthrostim Manipulator K973914 FRAS, Sense Technology, Inc. K003185 Full Spectrum Activator III K010851 Harrison Hand Held Adjusting Instrument Panel:… | 2001 |
| * | K010851 | Harrison Hand Held Adjusting InstrumentSummary page 1…tor K973914 FRAS, Sense Technology, Inc. K003185 Full Spectrum Activator III K010851 Harrison Hand Held Adjusting Instrument Panel: Physical Medicine Performance Standards: None known… | 2001 |
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K160278 (Spinal Acoustics, LLC, 2016) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K023462.
How does its category compare?
All LXM devicesLXM Manipulator, Plunger-Like Joint: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Impulse iQ Adjusting Instrument is intended for chiropractic adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine and/or extremities, or for soft-tissue musculoskeletal mobilization by a licensed health care professional only. For external use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080261 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080261: Impulse IQ Adjusting Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080261
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