510(k) · Cleared
ClearedDyonics Vision 325Z DV3-CCD Hermes Ready Camera System, Model 7209531
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 22, 2003 after a 21-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- May 22, 2003
- Review
- 21 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK031379 Dyonics Vision 325Z DV3-CCD Hermes Ready Camera System, Model 7209531Smith & Nephew, Inc. · 2003
- Descendant · cites it directly · 9 of its ownK070266 560 High Definition Camera SystemSmith & Nephew, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 7 of its ownK101734 Visionscope High Definition Endoscopy Camera System with; Camera…Visionscope Technologies, LLC · 2010
- Descendant · 2 generations on · 6 of its ownK153606 LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS…Smith & Nephew · 2016
- Descendant · 3 generations on · 3 of its ownK190367 Smith & Nephew Tablet ApplicationSmith & Nephew · 2019
- Descendant · 4 generations on · 2 of its ownK192876 INTELLIO Tablet ApplicationSmith & Nephew · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K070266560 High Definition Camera SystemSmith & Nephew, Inc. · 2007 · cites it directly9descendants
- K101734Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera…Visionscope Technologies, LLC · 2010 · 2 generations on7descendants
- K153606LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera…Smith & Nephew · 2016 · 2 generations on6descendants
- K190367Smith & Nephew Tablet ApplicationSmith & Nephew · 2019 · 3 generations on3descendants
- K192876INTELLIO Tablet ApplicationSmith & Nephew · 2020 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031379 | Dyonics Vision 325Z DV3-CCD Hermes Ready Camera System, Model 7209531 | Smith & Nephew, Inc. | 2003 | — |
| +1 | K070266 | 560 High Definition Camera System | Smith & Nephew, Inc. | 2007 | 1 |
| +2 | K101734 | Visionscope High Definition Endoscopy Camera System with; Camera Control Unit… | Visionscope Technologies, LLC | 2010 | — |
| +2 | K153606 | LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head… | Smith & Nephew | 2016 | — |
| +3 | K190367 | Smith & Nephew Tablet Application | Smith & Nephew | 2019 | — |
| +4 | K192876 | INTELLIO Tablet Application | Smith & Nephew | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 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 |
|---|---|---|---|
| * | — | Images Digital 3-Chip Color Video Camera Named without a submission number |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070266 | 560 High Definition Camera System | 2007 | 9 |
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?
- Of its descendants, K070266 (Smith & Nephew, Inc., 2007) has gone furthest, with 9 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The Smith & Nephew DyonicsQ Vision 3252 DV 3-CCD Color Video Camera System is indicated for use in endoscopic surgical procedures to allow visualization of the articular cavities, body cavities, hollow organs and canals, when used with an appropriately indicated endoscope.
Additionally, when used in conjunction with a Dyonics@ light source and light cable, the 3252 DV Camera System is indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031379 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031379: Dyonics Vision 325Z DV3-CCD Hermes Ready Camera System, Model 7209531.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031379
Report an extraction error
Are you the manufacturer?
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