510(k) · Cleared
ClearedDyonics Vision 635 Digital Capture System, Model 7209088
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 Sep 19, 2001 as substantially equivalent to K000380 (Hamilton Thorne Research, 2000) after a 90-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.
- Decided
- Sep 19, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000380 (2000). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK000380 FotomasterHamilton Thorne Research · 2000
- This deviceK011944 Dyonics Vision 635 Digital Capture System, Model 7209088Smith & Nephew, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK030728 Fyrelink VLMpacs, LLC · 2003
- Descendant · cites it directly · 0 of its ownK023053 Dyonics Vision 635 Image Management SystemSmith & Nephew, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK021236 Surgery and AccessoriesCamtronics, Ltd. · 2002
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000380 | Fotomaster | Hamilton Thorne Research | 2000 | — |
| 0 (this device) | K011944 | Dyonics Vision 635 Digital Capture System, Model 7209088 | Smith & Nephew, Inc. | 2001 | — |
| +1 | K030728 | Fyrelink VL | Mpacs, LLC | 2003 | — |
| +1 | K023053 | Dyonics Vision 635 Image Management System | Smith & Nephew, Inc. | 2002 | — |
| +1 | K021236 | Surgery and Accessories | Camtronics, Ltd. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 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 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 |
|---|---|---|---|
| * | K000380 | Fotomaster | 2000 |
What descends from it? (3)
3 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?
- Its one ancestor has no recall.
- Of its descendants, K030728 (Mpacs, LLC, 2003) has gone furthest, with 0 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 Dyonics Vision 635 Digital Capture System is indicated to be used in the operating room to digitally capture intra-operative still and motion images using the camera head, the foot switch, the front panel of the capture unit or the keyboard. Images are then stored in one of several standard image file formats on transportable media or to an Ethernet network for long term archival, retrieval or printing using third party image application software.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011944 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011944: Dyonics Vision 635 Digital Capture System, Model 7209088.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011944
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026