510(k) · Cleared
ClearedENDOCAM Flex HD Camera System 5521
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 Jan 11, 2017 as substantially equivalent to K080977 (Richard Wolf Medical Instruments Corp., 2008) and 1 other predicate after a 258-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Jan 11, 2017
- Review
- 258 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K950862 (1995). 14 ancestors in all, the oldest K942817 (1994). No later device cites it as a predicate yet.
- 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 deviceK161204 ENDOCAM Flex HD Camera System 5521Richard Wolf Medical Instruments Corporation · 2017
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) | K161204 | ENDOCAM Flex HD Camera System 5521 | Richard Wolf Medical Instruments Corporation | 2017 | — |
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 |
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 |
|---|---|---|---|
| * | K080977 | 3 CCD Endocam 5550Summary page 4…1 (21 CFR 876.1500, Product Code FET) Information on devices to which substantial equivalence is claimed: 510(k) Trade or proprietary or model name Manufacturer Number K080977 3 CCD HD ENDOCAM® 5550 Richard Wolf Medical Instruments Endoscopic Video camera system Corporation K130423 THE RICHARD WOLF ENDOC… | 2008 |
| * | K130423 | The Richard Wolf Endocam Logic HD Camera System 5525Summary page 4…510(k) Trade or proprietary or model name Manufacturer Number K080977 3 CCD HD ENDOCAM® 5550 Richard Wolf Medical Instruments Endoscopic Video camera system Corporation K130423 THE RICHARD WOLF ENDOCAM LOGIC |Richard Wolf Medical Instruments HD CAMERA SYSTEM 5525 Corporation 5. 510(k) Summary 5-1 of 4… | 2013 |
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?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 1 other device also cites its predicate K080977.
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. 2017, 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 Flex HD Controller has been designed for video endoscopy and can be used for both diagnostic and
therapeutic interventions.
The camera controller has an HDMI output suitable for connecting an image output device (monitor).
This product is designed exclusively for use by specialized medical personnel and may only be applied by medically
qualified and adequately trained persons.
The 1-chip HD camera head 5521902 is used for diagnostic and therapeutic operations in conjunction with ENDOCAM
Flex HD Controller 5521101.
This product is designed exclusively for use by specialized medical personnel and may only be applied by medically
qualified and adequately trained persons.
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/K161204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161204: ENDOCAM Flex HD Camera System 5521.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161204
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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