510(k) · Cleared
Cleared1-CCD Endocam 5520 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Jan 29, 2003 as substantially equivalent to K982965 (Richard Wolf Medical Instruments Corp., 1998) and 4 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1994. 10 later devices descend from it.
- Decided
- Jan 29, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K942817 (1994). 6 ancestors in all. 10 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK942817 CCD Endocam Office 5510Richard Wolf Medical Instruments Corp. · 1994
- 1 generation backK982965 Endocam Camera Systems 5502/5507 with CR Camera Heads and AccessoriesRichard Wolf Medical Instruments Corp. · 1998
- This deviceK023659 1-CCD Endocam 5520 SystemRichard Wolf Medical Instruments Corp. · 2003
- Descendant · cites it directly · 7 of its ownK080977 3 CCD Endocam 5550Richard Wolf Medical Instruments Corp. · 2008
- Descendant · cites it directly · 6 of its ownK130423 The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013
- Descendant · 2 generations on · 4 of its ownK180583 Logic 4K Camera Controller, Logic 4K Camera HeadRichard Wolf Medical Instruments Corporation · 2018
- Descendant · 3 generations on · 2 of its ownK200617 Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic…Richard Wolf Medical Instruments Corporation · 2020
- Descendant · 3 generations on · 0 of its ownK252858 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)Kms Medical Technology Co., Ltd. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K0809773 CCD Endocam 5550Richard Wolf Medical Instruments Corp. · 2008 · cites it directly7descendants
- K130423The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013 · cites it directly6descendants
- K180583Logic 4K Camera Controller, Logic 4K Camera HeadRichard Wolf Medical Instruments Corporation · 2018 · 2 generations on4descendants
- K200617Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller…Richard Wolf Medical Instruments Corporation · 2020 · 3 generations on2descendants
- K2528584K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)Kms Medical Technology Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942817 | CCD Endocam Office 5510 | Richard Wolf Medical Instruments Corp. | 1994 | — |
| −1 | K982965 | Endocam Camera Systems 5502/5507 with CR Camera Heads and Accessories | Richard Wolf Medical Instruments Corp. | 1998 | — |
| 0 (this device) | K023659 | 1-CCD Endocam 5520 System | Richard Wolf Medical Instruments Corp. | 2003 | — |
| +1 | 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 | — |
| +2 | K180583 | Logic 4K Camera Controller, Logic 4K Camera Head | Richard Wolf Medical Instruments Corporation | 2018 | — |
| +3 | K200617 | Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera… | Richard Wolf Medical Instruments Corporation | 2020 | — |
| +3 | K252858 | 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) | Kms Medical Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K982965 | Endocam Camera Systems 5502/5507 with CR Camera Heads and AccessoriesSummary page 4…ormation on devices to which substantial equivalence is claimed: 510(k) Number Trade or proprietary or model name Manufacturer 1 1-CCD endocam 5502 and 3-CCD endocam , 1 K982965 5507 with CF camera heads 1 Richard Wolt 2 1-CCD multi-endocam 5502 with electronic . 2 K983279 CCD endoscope 2 Richard Wolf 3 K9… | 1998 |
| * | K983279 | Endocam Camera Systems 5502 with Electronic CCD EndoscopeSummary page 4…ary or model name Manufacturer 1 1-CCD endocam 5502 and 3-CCD endocam , 1 K982965 5507 with CF camera heads 1 Richard Wolt 2 1-CCD multi-endocam 5502 with electronic . 2 K983279 CCD endoscope 2 Richard Wolf 3 K950502 3 1-CCD endocam 5501 3 Richard Wolf 4 K002328 4 SI0S-Intertace for 3CCD Endocam 5507.752 |… | 1998 |
| * | K950502 | CCD Endocam 5501Summary page 4…endocam 5502 and 3-CCD endocam , 1 K982965 5507 with CF camera heads 1 Richard Wolt 2 1-CCD multi-endocam 5502 with electronic . 2 K983279 CCD endoscope 2 Richard Wolf 3 K950502 3 1-CCD endocam 5501 3 Richard Wolf 4 K002328 4 SI0S-Intertace for 3CCD Endocam 5507.752 |4 Richard Wolf 5 K964173 5 C-mount obje… | 1995 |
| * | K002328 | Sios-Interface for Auto Light Projector, Sios-Interface for 3 CCD Endocam…Summary page 4…7 with CF camera heads 1 Richard Wolt 2 1-CCD multi-endocam 5502 with electronic . 2 K983279 CCD endoscope 2 Richard Wolf 3 K950502 3 1-CCD endocam 5501 3 Richard Wolf 4 K002328 4 SI0S-Intertace for 3CCD Endocam 5507.752 |4 Richard Wolf 5 K964173 5 C-mount objective lenses, autoclavable 5 Richard Wolf 1.0… | 2001 |
| * | K964173 | C-Mount Objective Lens F = 17 MM, Steam-Sterilizable: Model 85 261.172, C-Mount…Summary page 4…electronic . 2 K983279 CCD endoscope 2 Richard Wolf 3 K950502 3 1-CCD endocam 5501 3 Richard Wolf 4 K002328 4 SI0S-Intertace for 3CCD Endocam 5507.752 |4 Richard Wolf 5 K964173 5 C-mount objective lenses, autoclavable 5 Richard Wolf 1.0 Description The 1-CCD Endocam 5520 device is a further development o… | 1996 |
What descends from it? (10)
4 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 9 years and passes through 1 company; a new generation was cleared every 4.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K080977 (Richard Wolf Medical Instruments Corp., 2008) has gone furthest, with 7 descendants of its own.
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 1 CCD ENDOCAM 5520 is designed for video endoscopy and video microscopy and can be used for diagnostic and therapeutic applications.
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/K023659 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023659: 1-CCD Endocam 5520 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023659
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