510(k) · Cleared
ClearedDyonics Vision 337 Autoclavable Camera Head Model 7209048; Dyonics Autoclavable Camera Coupler Model 7207905
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Feb 2, 2001 as substantially equivalent to K972471 (Smith & Nephew, Inc., 1997) and 1 other predicate after a 63-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Feb 2, 2001
- Review
- 63 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K914919 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK914919 Smith & Nephew Dyonics Laparoscopy SystemSmith & Nephew Dyonics, Inc. · 1992
- This deviceK003710 Dyonics Vision 337 Autoclavable Camera Head Model 7209048; Dyonics…Smith & Nephew, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914919 | Smith & Nephew Dyonics Laparoscopy System | Smith & Nephew Dyonics, Inc. | 1992 | — |
| 0 (this device) | K003710 | Dyonics Vision 337 Autoclavable Camera Head Model 7209048; Dyonics… | Smith & Nephew, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 FET? 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 FET device
- #1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K972471 | Digital 3-Chip Color Video Camera, Illuminators, Video Components and AccessoriesSummary page 4…a Coupler Common Name: Camera Head and Camera Coupler Classification Name: Endoscope and/or Accessories D. Predicate Devices Dyonics Digital 3-Chip Color Video Camera K972471 Dyonics DyoCam Video Camera K914919 Dyonics Camera Coupler K972471 E. Description of Device The proposed Dyonics Vision 337 Au… | 1997 |
| * | K914919 | Smith & Nephew Dyonics Laparoscopy SystemSummary page 4…nd Camera Coupler Classification Name: Endoscope and/or Accessories D. Predicate Devices Dyonics Digital 3-Chip Color Video Camera K972471 Dyonics DyoCam Video Camera K914919 Dyonics Camera Coupler K972471 E. Description of Device The proposed Dyonics Vision 337 Autoclavable Camera Head and Camera Co… | 1992 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All FET devicesFET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FET
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FET
166in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FET
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FET
14,530in 2025
MAUDE reports naming product code FET, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 25 |
| 2017 | 3 | 119 | 0 | 66 |
| 2018 | 3 | 98 | 0 | 67 |
| 2019 | 3 | 25 | 0 | 72 |
| 2020 | 5 | 106 | 0 | 3,043 |
| 2021 | 1 | — | 0 | 5,300 |
| 2022 | 2 | — | 0 | 6,156 |
| 2023 | 1 | — | 2 | 8,199 |
| 2024 | 2 | — | 1 | 13,153 |
| 2025 | 6 | 166 | 0 | 14,530 |
| 2026 | 3 | 69 | 0 | — |
What is it indicated for?
The Dyonics Vision 337 Autoclavable Camera Head and Camera Coupler are indicated for use in endoscopic surgical procedures to provide illumination and allow visualization of articular cavities, body cavities, hollow organs and canals when used in conjunction with an appropriately indicated endoscope.
Additionally, the Dyonics Vision 337 Autoclavable Camera Head and Camera Coupler are indicated for use in endoscopic surgical procedures in the thoracic cavitity when used in conjunction with an appropriately indicated thoracoscope.
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/K003710 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003710: Dyonics Vision 337 Autoclavable Camera Head Model 7209048; Dyonics Autoclavable Camera Coupler Model 7207905.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003710
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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