510(k) · Cleared
ClearedVisionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera Handpiece; Visionscope Endoscopes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visionscope Technologies, LLC · HRX Arthroscope
Cleared on Sep 8, 2010 as substantially equivalent to K072879 (Biomet Orthopedics, Inc., 2008) and 5 other predicates after a 79-day review. Its family tree reaches back 5 generations to 1983. 7 later devices descend from it.
- Decided
- Sep 8, 2010
- Review
- 79 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K833587 (1983). 34 ancestors in all, the oldest K771218 (1978). 7 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 4 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
- 3 generations backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- 2 generations backK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
- 1 generation backK072675 Smith & Nephew ArthroscopeSmith & Nephew, Inc. · 2007
- This deviceK101734 Visionscope High Definition Endoscopy Camera System with; Camera…Visionscope Technologies, LLC · 2010
- Descendant · cites it directly · 6 of its ownK153606 LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS…Smith & Nephew · 2016
- Descendant · 2 generations on · 3 of its ownK190367 Smith & Nephew Tablet ApplicationSmith & Nephew · 2019
- Descendant · 3 generations on · 2 of its ownK192876 INTELLIO Tablet ApplicationSmith & Nephew · 2020
- Descendant · 4 generations on · 1 of its ownK203566 Tablet ApplicationSmith & Nephew · 2021
- Descendant · 2 generations on · 1 of its ownK191177 LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit -…Smith and Nephew, Inc. · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K153606LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera…Smith & Nephew · 2016 · cites it directly6descendants
- K190367Smith & Nephew Tablet ApplicationSmith & Nephew · 2019 · 2 generations on3descendants
- K192876INTELLIO Tablet ApplicationSmith & Nephew · 2020 · 3 generations on2descendants
- K203566Tablet ApplicationSmith & Nephew · 2021 · 4 generations on1descendant
- K191177LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K…Smith and Nephew, Inc. · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K833587 | Disposable Arthroscopy Blade | Dyonics, Inc. | 1983 | — |
| −4 | K900070 | Modified Uses of the Arthroscopic Surgical System | Dyonics, Inc. | 1990 | — |
| −3 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| −2 | K043395 | Smith & Nephew Videoarthroscope | Smith & Nephew, Inc. | 2005 | — |
| −1 | K072675 | Smith & Nephew Arthroscope | Smith & Nephew, Inc. | 2007 | — |
| 0 (this device) | K101734 | Visionscope High Definition Endoscopy Camera System with; Camera Control Unit… | Visionscope Technologies, LLC | 2010 | — |
| +1 | K153606 | LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head… | Smith & Nephew | 2016 | — |
| +2 | K190367 | Smith & Nephew Tablet Application | Smith & Nephew | 2019 | — |
| +3 | K192876 | INTELLIO Tablet Application | Smith & Nephew | 2020 | — |
| +4 | K203566 | Tablet Application | Smith & Nephew | 2021 | — |
| +2 | K191177 | LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi… | Smith and Nephew, Inc. | 2019 | — |
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 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K072879 | Innervue Diagnostic Scope SystemSummary page 1…tic Arthroscope (21 CFR §888.1 100) 5. Predicate Devices: Primary: InnerVue Diagnostic Scope System K072879 Arthrotek Inc. (Biomnet) Secondary: Smith & Nephew HD Camera System K070266 Smith & Nephe… | 2008 |
| * | K070266 | 560 High Definition Camera SystemSummary page 1…InnerVue Diagnostic Scope System K072879 Arthrotek Inc. (Biomnet) Secondary: Smith & Nephew HD Camera System K070266 Smith & Nephew Endoscopy Smith & Nephew Arthroscope K072675 Smith & Nephew Endoscopy… | 2007 |
| * | K072675 | Smith & Nephew ArthroscopeSummary page 1…Secondary: Smith & Nephew HD Camera System K070266 Smith & Nephew Endoscopy Smith & Nephew Arthroscope K072675 Smith & Nephew Endoscopy Stryker LED Light Source (L,9000) K082813 Stryker Endoscopy End… | 2007 |
| * | K082813 | Stryker Led LightsourceSummary page 1…phew Endoscopy Smith & Nephew Arthroscope K072675 Smith & Nephew Endoscopy Stryker LED Light Source (L,9000) K082813 Stryker Endoscopy EndoSheath K990354 Vision Sciences Inc. Smith &… | 2008 |
| * | K990354 | EndosheathSummary page 1…th & Nephew Endoscopy Stryker LED Light Source (L,9000) K082813 Stryker Endoscopy EndoSheath K990354 Vision Sciences Inc. Smith & Nephew 660HD Image K060777 Smith & Nephew Endoscopy M… | 1999 |
| * | K060777 | Smith & Nephew Model 660HD Image Management SystemSummary page 1…Stryker Endoscopy EndoSheath K990354 Vision Sciences Inc. Smith & Nephew 660HD Image K060777 Smith & Nephew Endoscopy Management System ______ ______________ 510(k) Summa… | 2006 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153606 | LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera… | 2016 | 6 |
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 3 companies; a new generation was cleared every 6.3 years on median.
- 4 of the 34 ancestors have a recall of any class.
- Of its descendants, K153606 (Smith & Nephew, 2016) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K072879.
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 VisionScope High Definition Endoscopy Camera System is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination, visualization and capture of still and motion pictures of an interior cavity of the body through a natural or surgical opening. Examples of generic surgical use include imaging of articular cavities, body cavities, hollow organs and canals. Additionally, when used in conjunction with an…
Read the full statement (117 words)
The VisionScope High Definition Endoscopy Camera System is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination, visualization and capture of still and motion pictures of an interior cavity of the body through a natural or surgical opening. Examples of generic surgical use include imaging of articular cavities, body cavities, hollow organs and canals.
Additionally, when used in conjunction with an appropriately indicated and FDA 5 10(k)-cleared endoscope and light source, the VisionScope High Definition Endoscopy Camera Control Unit and Camera Handpiece are indicated for use in arthroscopic and endoscopic surgical procedures to provide illumnination, visualization and capture of still and motion pictures of articular cavities, body cavities, hollow organs and canals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101734 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101734: Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera Handpiece; Visionscope Endoscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101734
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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