510(k) · Cleared
ClearedLogic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corporation · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Jun 23, 2020 as substantially equivalent to K180583 (Richard Wolf Medical Instruments Corporation, 2018) after a 106-day review. Its family tree reaches back 7 generations to 1995. 2 later devices descend from it.
- Decided
- Jun 23, 2020
- Review
- 106 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K950862 (1995). 15 ancestors in all, the oldest K942817 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK950862 Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format)…Karl Storz Imaging, Inc. · 1995
- 6 generations backK983566 3-Chip Video CameraStryker Endoscopy · 1999 · Recalled
- 5 generations backK031098 3-CCD Digital Camera SystemLinvatec Corp. · 2003
- 4 generations backK063457 Truehd (1080P) Digital Camera SystemConmed Linvatec · 2006
- 3 generations backK080977 3 CCD Endocam 5550Richard Wolf Medical Instruments Corp. · 2008
- 2 generations backK130423 The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013
- 1 generation backK180583 Logic 4K Camera Controller, Logic 4K Camera HeadRichard Wolf Medical Instruments Corporation · 2018
- This deviceK200617 Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic…Richard Wolf Medical Instruments Corporation · 2020
- Descendant · cites it directly · 0 of its ownK212808 Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation · 2022
- Descendant · cites it directly · 0 of its ownK211332 D Camera ControllerRichard Wolf Medical Instruments Corporation · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K950862 | Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color… | Karl Storz Imaging, Inc. | 1995 | — |
| −6 | K983566 | 3-Chip Video Camera | Stryker Endoscopy | 1999 | 1 |
| −5 | K031098 | 3-CCD Digital Camera System | Linvatec Corp. | 2003 | — |
| −4 | K063457 | Truehd (1080P) Digital Camera System | Conmed Linvatec | 2006 | — |
| −3 | K080977 | 3 CCD Endocam 5550 | Richard Wolf Medical Instruments Corp. | 2008 | — |
| −2 | K130423 | The Richard Wolf Endocam Logic HD Camera System 5525 | Richard Wolf Medical Instruments Corp. | 2013 | — |
| −1 | K180583 | Logic 4K Camera Controller, Logic 4K Camera Head | Richard Wolf Medical Instruments Corporation | 2018 | — |
| 0 (this device) | K200617 | Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera… | Richard Wolf Medical Instruments Corporation | 2020 | — |
| +1 | K212808 | Logic Hd camera head green, System green | Richard Wolf Medical Instruments Corporation | 2022 | — |
| +1 | K211332 | D Camera Controller | Richard Wolf Medical Instruments Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K180583 | Logic 4K Camera Controller, Logic 4K Camera HeadSummary page 5…Page 2 of 5 05 510(k) Summary III Predicate Device Name of Predicate Device: LOGIC 4K CAMERA CONTROLLER (5525301) 510(k) Number: K180583 Regulatory Class: II Product Code: FET Manufacturer: Richard Wolf GmbH The predicate has no… | 2018 |
What descends from it? (2)
2 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 25 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K212808 (Richard Wolf Medical Instruments Corporation, 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K180583.
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. 2020, this device’s year, is highlighted.
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?
ENDOCAM Logic 5525 Camera Controller:
LOGIC HD CAMERA CONTROLLER / LOGIC 4K CAMERA CONTROLLER:
The Logic HD Camera Controller and the Logic 4K Camera Controller have been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The Camera Controllers are used in conjunction with other video equipment and endoscopic accessories.
LOGIC HD LITE CAMERA CONTROLLER:
The Logic HD lite Camera Controller has been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The Camera Controller is used in conjunction with other video equipment and endoscopic accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200617: Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200617
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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