510(k) · Cleared
ClearedAtlas Percussion Adjusting Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinalight, Inc. · LXM Manipulator, Plunger-Like Joint
Cleared on Jun 20, 2018 as substantially equivalent to K946258 (Spinalight, Inc., 1995) after a 302-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jun 20, 2018
- Review
- 302 days
- Class
- Class U
- Product code
- LXM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K946258 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK946258 Model 8000 Atlas C-1 Orthogonal Adjusting InstrumentSpinalight, Inc. · 1995 · Recalled
- This deviceK172536 Atlas Percussion Adjusting InstrumentSpinalight, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946258 | Model 8000 Atlas C-1 Orthogonal Adjusting Instrument | Spinalight, Inc. | 1995 | 1 |
| 0 (this device) | K172536 | Atlas Percussion Adjusting Instrument | Spinalight, Inc. | 2018 | — |
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? (1)
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 |
|---|---|---|---|
| * | K946258 | Model 8000 Atlas C-1 Orthogonal Adjusting InstrumentSummary page 4…Regulation Number: None III. PREDICATE DEVICE Device: The Atlas Adjusting Instrument, Model 8000 Manufacturer: Spinalight, Inc 510(k) Reg. No: K946258 This predicate device has not been subject to a design‐related recall. Regulatory Class: Unclassified Produc… | 1995 |
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?
- Its one ancestor has a recall.
How does its category compare?
All LXM devicesLXM Manipulator, Plunger-Like Joint: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Spinalight Atlas Percussion Instrument is to be used by a licensed Chiropractor to assist in making a Chiropractic adjustment to the atlas vertebrae. This adjustment is indicated when the doctor believes this bone to be out of alignment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172536: Atlas Percussion Adjusting Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172536
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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