510(k) · Cleared
ClearedMax Adjusting Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Manna Omni International, Inc. · LXM Manipulator, Plunger-Like Joint
Cleared on Aug 13, 2008 as substantially equivalent to K080261 (Neuromechanical Innovations, LLC, 2008) and 2 other predicates after a 7-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Aug 13, 2008
- Review
- 7 days
- Class
- Class U
- Product code
- LXM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K930431 (1994). 10 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 backK072519 Activator V Spinal Adjusting InstrumentActivator Methods International, Ltd. · 2007
- This deviceK082218 Max Adjusting InstrumentManna Omni International, Inc. · 2008
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 | K072519 | Activator V Spinal Adjusting Instrument | Activator Methods International, Ltd. | 2007 | — |
| 0 (this device) | 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 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K080261 | Impulse IQ Adjusting InstrumentSummary page 1…Chiropractic adjusting instrument Classification name Manipulator, plunger-like joint (a)(3) Legally marketed devices K080261 Impulse iQ Adjusting Instrument for substantial equivalence K072519 Activator V Spinal Adjusting Instrument… | 2008 |
| * | K072519 | Activator V Spinal Adjusting InstrumentSummary page 1…Manipulator, plunger-like joint (a)(3) Legally marketed devices K080261 Impulse iQ Adjusting Instrument for substantial equivalence K072519 Activator V Spinal Adjusting Instrument K010851 Harrison Hand Held Adjusting Instrument… | 2007 |
| * | K010851 | Harrison Hand Held Adjusting InstrumentSummary page 1…80261 Impulse iQ Adjusting Instrument for substantial equivalence K072519 Activator V Spinal Adjusting Instrument K010851 Harrison Hand Held Adjusting Instrument (a)(4) Device description MAX is a hand-held chiropractic adjusting ins… | 2001 |
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 14 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K080261.
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?
MAX is indicated for chiropractic adjustment of the spine and/or extremities. MAX should be used by a licensed health care professional only. Intended for external use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082218 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082218: Max Adjusting Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082218
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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