510(k) · Cleared
Recalled · Class II · 2022SX-One MicroKnife
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonex Health, Inc. · LXH Orthopedic Manual Surgical Instrument
Cleared on Dec 20, 2019 as substantially equivalent to K943873 (Orthomet, Inc., 1995) after a 73-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 20, 2019
- Review
- 73 days
- Class
- Class I
- Product code
- LXH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943873 (1995). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K252594UltraGuideCTR® image guided soft tissue release systemSonex Health · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943873 | Orthomet Anatomically Guided Carpal Tunnel Release SY | Orthomet, Inc. | 1995 | — |
| 0 (this device) | K192873 | SX-One MicroKnife | Sonex Health, Inc. | 2019 | — |
| +1 | K252594 | UltraGuideCTR® image guided soft tissue release system | Sonex Health | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 LXH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K943873 | Orthomet Anatomically Guided Carpal Tunnel Release SYSummary page 4…me: Orthopedic Manual Surgical Instrument Product Code: LXH Primary Predicate Device: Orthomet Anatomically Guided Carpal Tunnel Release (K943873) Reference Device: LB Medical Inflatable Tissue Elevator/Expander System (K080158)… | 1995 |
| † | K080158 | LB Medical Inflatable Tissue Elevator/Expander System | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252594 | UltraGuideCTR® image guided soft tissue release system | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 29, 2022 | Class II | Z-1387-2022 | Process control | Potential of dull blade |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K252594 (Sonex Health, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LXH devicesLXH Orthopedic Manual Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LXH
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · LXH
Too few LXH 510(k)s in any year since 2007 to give a median.
Recalls per year · LXH
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXH
6,119in 2025
MAUDE reports naming product code LXH, 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 | 0 | — | 41 | 398 |
| 2008 | 0 | — | 41 | 833 |
| 2009 | 0 | — | 25 | 1,569 |
| 2010 | 1 | — | 54 | 2,329 |
| 2011 | 0 | — | 12 | 2,488 |
| 2012 | 0 | — | 29 | 2,059 |
| 2013 | 0 | — | 17 | 4,149 |
| 2014 | 1 | — | 12 | 3,844 |
| 2015 | 0 | — | 7 | 5,944 |
| 2016 | 0 | — | 9 | 6,365 |
| 2017 | 0 | — | 14 | 4,133 |
| 2018 | 0 | — | 23 | 4,685 |
| 2019 | 1 | — | 10 | 5,224 |
| 2020 | 0 | — | 3 | 4,766 |
| 2021 | 0 | — | 2 | 4,832 |
| 2022 | 0 | — | 4 | 4,844 |
| 2023 | 0 | — | 4 | 5,163 |
| 2024 | 0 | — | 3 | 6,319 |
| 2025 | 0 | — | 0 | 6,119 |
| 2026 | 0 | — | 8 | — |
What is it indicated for?
The SX-One MicroKnife is a disposable device intended to create space within the carpal tunnel and transect the
transverse carpal ligament (TCL) for the treatment of carpal tunnel syndrome.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192873 · printed Nov 4, 2026
Cite this page
510(k) Report. “K192873: SX-One MicroKnife.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K192873
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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