510(k) · Cleared
ClearedLogic 4K Camera Controller, Logic 4K Camera Head
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 28, 2018 as substantially equivalent to K130423 (Richard Wolf Medical Instruments Corp., 2013) after a 115-day review. Its family tree reaches back 6 generations to 1995. 4 later devices descend from it.
- Decided
- Jun 28, 2018
- Review
- 115 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K950862 (1995). 14 ancestors in all, the oldest K942817 (1994). 4 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK950862 Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format)…Karl Storz Imaging, Inc. · 1995
- 5 generations backK983566 3-Chip Video CameraStryker Endoscopy · 1999 · Recalled
- 4 generations backK031098 3-CCD Digital Camera SystemLinvatec Corp. · 2003
- 3 generations backK063457 Truehd (1080P) Digital Camera SystemConmed Linvatec · 2006
- 2 generations backK080977 3 CCD Endocam 5550Richard Wolf Medical Instruments Corp. · 2008
- 1 generation backK130423 The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013
- This deviceK180583 Logic 4K Camera Controller, Logic 4K Camera HeadRichard Wolf Medical Instruments Corporation · 2018
- Descendant · cites it directly · 2 of its ownK200617 Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic…Richard Wolf Medical Instruments Corporation · 2020
- Descendant · cites it directly · 0 of its ownK252858 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)Kms Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK212808 Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK211332 D Camera ControllerRichard Wolf Medical Instruments Corporation · 2021
Most influential descendants
Showing 4 of 4 · See all- K200617Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller…Richard Wolf Medical Instruments Corporation · 2020 · cites it directly2descendants
- K2528584K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)Kms Medical Technology Co., Ltd. · 2026 · cites it directly0descendants
- K212808Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation · 2022 · cites it directly0descendants
- K211332D Camera ControllerRichard Wolf Medical Instruments Corporation · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K950862 | Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color… | Karl Storz Imaging, Inc. | 1995 | — |
| −5 | K983566 | 3-Chip Video Camera | Stryker Endoscopy | 1999 | 1 |
| −4 | K031098 | 3-CCD Digital Camera System | Linvatec Corp. | 2003 | — |
| −3 | K063457 | Truehd (1080P) Digital Camera System | Conmed Linvatec | 2006 | — |
| −2 | K080977 | 3 CCD Endocam 5550 | Richard Wolf Medical Instruments Corp. | 2008 | — |
| −1 | K130423 | The Richard Wolf Endocam Logic HD Camera System 5525 | Richard Wolf Medical Instruments Corp. | 2013 | — |
| 0 (this device) | K180583 | Logic 4K Camera Controller, Logic 4K Camera Head | Richard Wolf Medical Instruments Corporation | 2018 | — |
| +1 | K200617 | Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera… | Richard Wolf Medical Instruments Corporation | 2020 | — |
| +1 | K252858 | 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) | Kms Medical Technology Co., Ltd. | 2026 | — |
| +1 | K212808 | Logic Hd camera head green, System green | Richard Wolf Medical Instruments Corporation | 2022 | — |
| +2 | 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K130423 | The Richard Wolf Endocam Logic HD Camera System 5525Summary page 4…or model name Manufacturer Number THE RICHARD WOLF ENDOCAM® LOGIC HD Richard Wolf Medical Instruments K130423 CAMERA SYSTEM 5525 Corporation This predicate has not been subject to a d… | 2013 |
What descends from it? (4)
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?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K200617 (Richard Wolf Medical Instruments Corporation, 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K130423.
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. 2018, 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?
The ENDOCAM® Logic 4K Camera System 5525 has been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The ENDOCAM® Logic 4K Camera System 5525 is used in conjunction with other video equipment and endoscopic accessories.
Logic 4K Camera Head 85525942 is used for applications in conjunction with the Logic 4K Camera Controller 5525301 for diagnostic and therapeutic interventions.
This product is exclusively intended for use by specialized medical personnel and may only be used by adequately qualified and trained medical doctors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180583 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180583: Logic 4K Camera Controller, Logic 4K Camera Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180583
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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