510(k) · Cleared
ClearedActivator II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Activator Methods, Inc. · LXM Manipulator, Plunger-Like Joint
Cleared on Jan 27, 1998 as substantially equivalent to K950646 (Moyco Union Broach, Div., Moyco Technologies, Inc., 1996) and 1 other predicate after a 133-day review. Its family tree reaches back 1 generation to 1994. 6 later devices descend from it.
- Decided
- Jan 27, 1998
- Review
- 133 days
- Class
- Class U
- Product code
- LXM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930431 (1994). 2 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK930431 Arthrostim ManipulatorFreeman Procedure Seminars · 1994
- This deviceK973506 Activator IIActivator Methods, Inc. · 1998
- Descendant · cites it directly · 5 of its ownK023462 Impulse-Adjusting Instrument, CBP Adjusting Instrument…Neuromechanical Innovations, LLC · 2003
- Descendant · 2 generations on · 2 of its ownK080261 Impulse IQ Adjusting InstrumentNeuromechanical Innovations, LLC · 2008
- Descendant · 2 generations on · 1 of its ownK072519 Activator V Spinal Adjusting InstrumentActivator Methods International, Ltd. · 2007
- Descendant · 3 generations on · 0 of its ownK160278 VSTAAR AdjusteRSpinal Acoustics, LLC · 2016
- Descendant · 3 generations on · 0 of its ownK082218 Max Adjusting InstrumentManna Omni International, Inc. · 2008
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K023462Impulse-Adjusting Instrument, CBP Adjusting Instrument, Neuromechanical Adjusting…Neuromechanical Innovations, LLC · 2003 · cites it directly5descendants
- K080261Impulse IQ Adjusting InstrumentNeuromechanical Innovations, LLC · 2008 · 2 generations on2descendants
- K072519Activator V Spinal Adjusting InstrumentActivator Methods International, Ltd. · 2007 · 2 generations on1descendant
- K160278VSTAAR AdjusteRSpinal Acoustics, LLC · 2016 · 3 generations on0descendants
- K082218Max Adjusting InstrumentManna Omni International, Inc. · 2008 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930431 | Arthrostim Manipulator | Freeman Procedure Seminars | 1994 | — |
| 0 (this device) | K973506 | Activator II | Activator Methods, Inc. | 1998 | — |
| +1 | K023462 | Impulse-Adjusting Instrument, CBP Adjusting Instrument, Neuromechanical… | Neuromechanical Innovations, LLC | 2003 | — |
| +2 | K080261 | Impulse IQ Adjusting Instrument | Neuromechanical Innovations, LLC | 2008 | — |
| +2 | K072519 | Activator V Spinal Adjusting Instrument | Activator Methods International, Ltd. | 2007 | — |
| +3 | K160278 | VSTAAR AdjusteR | Spinal Acoustics, LLC | 2016 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K950646 | IntegratorSummary page 1…device Classification name: Plunger-li‘ke joint manipulator Substantially equivalent to: Activator® preamendments device Activator Methods Phoenix, Arizona Integrator K950646 HRI, Inc. Arthrostim K930431 Freeman Procedure Seminars Device Description: The Activator II ® is a chiropractic adjusting ins… | 1996 |
| * | K930431 | Arthrostim ManipulatorSummary page 1…unger-li‘ke joint manipulator Substantially equivalent to: Activator® preamendments device Activator Methods Phoenix, Arizona Integrator K950646 HRI, Inc. Arthrostim K930431 Freeman Procedure Seminars Device Description: The Activator II ® is a chiropractic adjusting instrument for use in spinal mani… | 1994 |
| * | — | Activator® preamendments device Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023462 | Impulse-Adjusting Instrument, CBP Adjusting Instrument, Neuromechanical Adjusting… | 2003 | 5 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K023462 (Neuromechanical Innovations, LLC, 2003) has gone furthest, with 5 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?
The Activator II® is indicated for chiropractic adjustment of the spine and extremities.
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/K973506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973506: Activator II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973506
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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