510(k) · Cleared
ClearedAkro VU Videoscopic Carpal Tunnel Release (VCTR) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skeletal Dynamics, LLC · HRX Arthroscope
Cleared on Oct 4, 2010 as substantially equivalent to K912871 (3M Health Care, Ltd., 1991) after a 395-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Oct 4, 2010
- Review
- 395 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912871 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK912871 Inside Job3M Health Care, Ltd. · 1991 · Recalled
- This deviceK092723 Akro VU Videoscopic Carpal Tunnel Release (VCTR) SystemSkeletal Dynamics, LLC · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912871 | Inside Job | 3M Health Care, Ltd. | 1991 | 2 |
| 0 (this device) | K092723 | Akro VU Videoscopic Carpal Tunnel Release (VCTR) System | Skeletal Dynamics, LLC | 2010 | — |
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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K912871 | Inside JobSummary page 2…eristics: The Akro-Vu Videoscopic Carpal Tunnel Release System has the following similarities to the Microaire CTRS manufactured and distributed by Microaire pursuant to K912871: * The same indications for use and intended use * The same basic general shape of the working instrument *… | 1991 |
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 HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The Akro-Vu Videoscopic Carnal Tunnel Release System (VCTR) is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e. idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a carnal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e. calcific tendonitis, fracture of the hook of the hamate). This device is indicated…
Read the full statement (104 words)
The Akro-Vu Videoscopic Carnal Tunnel Release System (VCTR) is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e. idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a carnal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e. calcific tendonitis, fracture of the hook of the hamate). This device is indicated solely for releasing the flexor retinaculumn (transverse carnal ligament).
Contraindications: The device is not intended for use in patients with known abnormalities of their wrist (carnal tunnel), including distal radial deformities, rheumatoid and other synovitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092723 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092723: Akro VU Videoscopic Carpal Tunnel Release (VCTR) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092723
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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