510(k) · Cleared
ClearedC-Mor Visualization Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axis Surgical Technologies, Inc. · HRX Arthroscope
Cleared on Mar 2, 2010 as substantially equivalent to K082293 (Biovision Technologies, LLC, 2008) and 2 other predicates after a 90-day review. Its family tree reaches back 6 generations to 1983. 16 later devices descend from it.
- Decided
- Mar 2, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K833587 (1983). 23 ancestors in all, the oldest K771218 (1978). 16 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 5 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
- 4 generations backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- 3 generations backK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
- 2 generations backK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
- 1 generation backK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
- This deviceK093717 C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010
- Descendant · cites it directly · 7 of its ownK141119 Camera Enabled ProbeTrice Medical, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK102733 Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology…Vision-Sciences, Inc. · 2011
- Descendant · 2 generations on · 6 of its ownK162475 mi-eye 2, mi-eye 2 monitorTrice Medical · 2016
- Descendant · 3 generations on · 2 of its ownK181982 MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc. · 2018
- Descendant · 4 generations on · 1 of its ownK243020 MIDASVuIntravu, Inc. · 2024
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K141119Camera Enabled ProbeTrice Medical, Inc. · 2014 · cites it directly7descendants
- K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences…Vision-Sciences, Inc. · 2011 · cites it directly7descendants
- K162475mi-eye 2, mi-eye 2 monitorTrice Medical · 2016 · 2 generations on6descendants
- K181982MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc. · 2018 · 3 generations on2descendants
- K243020MIDASVuIntravu, Inc. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K833587 | Disposable Arthroscopy Blade | Dyonics, Inc. | 1983 | — |
| −5 | K900070 | Modified Uses of the Arthroscopic Surgical System | Dyonics, Inc. | 1990 | — |
| −4 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| −3 | K043395 | Smith & Nephew Videoarthroscope | Smith & Nephew, Inc. | 2005 | — |
| −2 | K072879 | Innervue Diagnostic Scope System | Biomet Orthopedics, Inc. | 2008 | 2 |
| −1 | K082293 | Surgview Integrated Visualization System | Biovision Technologies, LLC | 2008 | — |
| 0 (this device) | K093717 | C-Mor Visualization Device | Axis Surgical Technologies, Inc. | 2010 | — |
| +1 | K141119 | Camera Enabled Probe | Trice Medical, Inc. | 2014 | — |
| +1 | K102733 | Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology… | Vision-Sciences, Inc. | 2011 | — |
| +2 | K162475 | mi-eye 2, mi-eye 2 monitor | Trice Medical | 2016 | — |
| +3 | K181982 | MIDAScope and Introducer Kit, and MIDASystem | Intravu, Inc. | 2018 | — |
| +4 | K243020 | MIDASVu | Intravu, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K082293 | Surgview Integrated Visualization SystemSummary page 1…Class 2 Predicate Devices: 510(k) Number Trade Name Manufacturer K082293 Surgview integrated visualization system Biovision Technologies,… | 2008 |
| * | K043395 | Smith & Nephew VideoarthroscopeSummary page 1…Biovision Technologies, _ __ ___ __ __ _ __ __ __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ LLC K043395 S&N Video Arthroscope Smith & Nepe K072879… | 2005 |
| * | K072879 | Innervue Diagnostic Scope SystemSummary page 1…_ _ _ _ _ _ _ _ _ _ _ LLC K043395 S&N Video Arthroscope Smith & Nepe K072879 InnerVue Diagnostic Scope System Biomet Intended Use!/ Indi… | 2008 |
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 5 companies; a new generation was cleared every 6.3 years on median.
- 2 of the 23 ancestors have a recall of any class.
- Of its descendants, K141119 (Trice Medical, Inc., 2014) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K082293.
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 Axis Surgical Technologies C-MOR Visualization Device is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093717 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093717: C-Mor Visualization Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093717
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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