510(k) Report

510(k) · Cleared

Cleared

The Richard Wolf Endocam Logic HD Camera System 5525

K130423510(k) TraditionalCleared Apr 3, 201342-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Richard Wolf Medical Instruments Corp. · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Cleared on Apr 3, 2013 as substantially equivalent to K080977 (Richard Wolf Medical Instruments Corp., 2008) and 2 other predicates after a 42-day review. Its family tree reaches back 5 generations to 1995. 6 later devices descend from it.

Decided
Apr 3, 2013
Review
42 days
Class
Class II
Product code
FET
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K950862 (1995). 13 ancestors in all, the oldest K942817 (1994). 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor1996: 1 other ancestor2001: 1 other ancestor1998: 2 other ancestors1995: 1 other ancestor1994: 1 other ancestor1997: 1 other ancestor2018: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant cleared2021: 1 descendant clearedK950862 · Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color Television Camera for Endoscopic Procedures · Karl Storz Imaging, Inc. · 1995K983566 · 3-Chip Video Camera · Stryker Endoscopy · 1999 · recalledK031098 · 3-CCD Digital Camera System · Linvatec Corp. · 2003K063457 · Truehd (1080P) Digital Camera System · Conmed Linvatec · 2006K080977 · 3 CCD Endocam 5550 · Richard Wolf Medical Instruments Corp. · 20081990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors3 generations back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K080977 · 3 CCD Endocam 5550 · Richard Wolf Medical Instruments Corp. · 2008K063457 · Truehd (1080P) Digital Camera System · Conmed Linvatec · 2006K031098 · 3-CCD Digital Camera System · Linvatec Corp. · 2003K983566 · 3-Chip Video Camera · Stryker Endoscopy · 1999 · recalledK950862 · Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color Television Camera for Endoscopic Procedures · Karl Storz Imaging, Inc. · 1995−50
  1. Root · 5 generations backK950862 Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format)…Karl Storz Imaging, Inc. · 1995
  2. 4 generations backK983566 3-Chip Video CameraStryker Endoscopy · 1999 · Recalled
  3. 3 generations backK031098 3-CCD Digital Camera SystemLinvatec Corp. · 2003
  4. 2 generations backK063457 Truehd (1080P) Digital Camera SystemConmed Linvatec · 2006
  5. 1 generation backK080977 3 CCD Endocam 5550Richard Wolf Medical Instruments Corp. · 2008
  6. This deviceK130423 The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013
  7. Descendant · cites it directly · 4 of its ownK180583 Logic 4K Camera Controller, Logic 4K Camera HeadRichard Wolf Medical Instruments Corporation · 2018
  8. Descendant · 2 generations on · 2 of its ownK200617 Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic…Richard Wolf Medical Instruments Corporation · 2020
  9. Descendant · 2 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
  10. Descendant · 2 generations on · 0 of its ownK212808 Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation · 2022
  11. Descendant · 3 generations on · 0 of its ownK211332 D Camera ControllerRichard Wolf Medical Instruments Corporation · 2021

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2017: 12018: 12020: 12021: 12022: 12026: 1
2017high 1 (2017) · low 0 (2019)2026

Most influential descendants

Showing 5 of 6 · See all
  • K180583Logic 4K Camera Controller, Logic 4K Camera HeadRichard Wolf Medical Instruments Corporation · 2018 · cites it directly4descendants
  • K200617Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller…Richard Wolf Medical Instruments Corporation · 2020 · 2 generations on2descendants
  • K2528584K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)Kms Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
  • K212808Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation · 2022 · 2 generations on0descendants
  • K211332D Camera ControllerRichard Wolf Medical Instruments Corporation · 2021 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K950862Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color…Karl Storz Imaging, Inc.1995—
−4K9835663-Chip Video CameraStryker Endoscopy19991
−3K0310983-CCD Digital Camera SystemLinvatec Corp.2003—
−2K063457Truehd (1080P) Digital Camera SystemConmed Linvatec2006—
−1K0809773 CCD Endocam 5550Richard Wolf Medical Instruments Corp.2008—
0 (this device)K130423The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp.2013—
+1K180583Logic 4K Camera Controller, Logic 4K Camera HeadRichard Wolf Medical Instruments Corporation2018—
+2K200617Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera…Richard Wolf Medical Instruments Corporation2020—
+2K2528584K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)Kms Medical Technology Co., Ltd.2026—
+2K212808Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation2022—
+3K211332D Camera ControllerRichard Wolf Medical Instruments Corporation2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
199610
199710
199820
200110
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
202010
202110
202210
202610
FIG. 1 — Lineage of K130423, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K0809773 CCD Endocam 5550Richard Wolf Medical Instruments Corp.2008—
*K0236591-CCD Endocam 5520 System
Summary page 4
…Logic Hf) Camera Systemi 5525 is subst ant inll equi va lent to thre exist iii& 510(k) cleared devices sold by: Richajrd Wolf Medical Instrumlents Corporation (K0809)77. K023659, and K964 173). Section! Pauc 5-15 of' 108 2 DEPARTMENT OF ilEALTil…
Richard Wolf Medical Instruments Corp.2003—
*K964173C-Mount Objective Lens F = 17 MM, Steam-Sterilizable: Model 85 261.172, C-Mount…
Summary page 1
…977 13 CCD ENDOCAM 3330 (Producs Code: GCJ) |1 Richard Wolf Medical Inst. Corp. 2 K023639 21 CCD ENDOCAM 5520 (Product Code: KOG) 12 Richard Wolt Medieal Inst. Corp. 3 K964173 3 C-mount objective fens. steam steritizable 3 Richard Wolf Medical Inst. Corp Section / Page 3-12 o 108…
Richard Wolf Medical Instruments Corp.1996—

Also cleared against K080977: 1 other device →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K180583Logic 4K Camera Controller, Logic 4K Camera HeadRichard Wolf Medical Instruments Corporation20184
K161204ENDOCAM Flex HD Camera System 5521Richard Wolf Medical Instruments Corporation20170

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 18 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
  • 1 of the 13 ancestors has a recall of any class.
  • Of its descendants, K180583 (Richard Wolf Medical Instruments Corporation, 2018) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K080977.

How does its category compare?

All FET devices

FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · FET

6in 2025

2007: 12008: 22009: 22010: 12011: 22012: 22013: 22015: 22016: 12017: 32018: 32019: 32020: 52021: 12022: 22023: 12024: 22025: 62026 (partial year): 3
2007high 6 (2025) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FET

166in 2025

2017: 119 days median2018: 98 days median2019: 25 days median2020: 106 days median2025: 166 days median2026 (partial year): 69 days median
2007high 166 (2025) · low 25 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FET

1in 2024

2023: 22024: 1
2007high 2 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FET

14,530in 2025

2007: 22008: 12009: 62010: 32011: 72012: 112013: 82014: 32015: 32016: 252017: 662018: 672019: 722020: 3,0432021: 5,3002022: 6,1562023: 8,1992024: 13,1532025: 14,530
2007high 14,530 (2025) · low 1 (2008)2025

MAUDE reports naming product code FET, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—02
20082—01
20092—06
20101—03
20112—07
20122—011
20132—08
20140—03
20152—03
20161—025
20173119066
2018398067
2019325072
2020510603,043
20211—05,300
20222—06,156
20231—28,199
20242—113,153
20256166014,530
20263690—

What is it indicated for?

The ENDOCAM® Logic HD Camera System 5525 has been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The ENDOCAM® Logic HD Camera System 5525 is used in conjunction with other video equipment and endoscopic accessories.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K130423: The Richard Wolf Endocam Logic HD Camera System 5525.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130423

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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