510(k) Report

510(k) · Cleared

Cleared

Iec Medsight and Medbright

K080809510(k) TraditionalCleared Aug 11, 2008143-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

Innovative Endoscopy Components, LLC · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Cleared on Aug 11, 2008 as substantially equivalent to K974391 (Karl Storz Imaging, Inc., 1998) and 9 other predicates after a 143-day review. Its family tree reaches back 3 generations to 1994.

Decided
Aug 11, 2008
Review
143 days
Class
Class II
Product code
FET
Recalls
None
Predicates
10

Its longest line of descent runs back 3 generations to K942817 (1994). 20 ancestors in all, the oldest K883943 (1988). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestor2001: 2 other ancestors2000: 1 other ancestor1999: 1 other ancestor1998: 3 other ancestors1996: 2 other ancestors1991: 1 other ancestor2003: 1 other ancestor1995: 3 other ancestors1994: 1 other ancestor1988: 1 other ancestorK942817 · CCD Endocam Office 5510 · Richard Wolf Medical Instruments Corp. · 1994K982965 · Endocam Camera Systems 5502/5507 with CR Camera Heads and Accessories · Richard Wolf Medical Instruments Corp. · 1998K023659 · 1-CCD Endocam 5520 System · Richard Wolf Medical Instruments Corp. · 2003198519901995200020052010
Other ancestors, by generation 1 generation back: 9 other ancestors2 generations back: 8 other ancestors K023659 · 1-CCD Endocam 5520 System · Richard Wolf Medical Instruments Corp. · 2003K982965 · Endocam Camera Systems 5502/5507 with CR Camera Heads and Accessories · Richard Wolf Medical Instruments Corp. · 1998K942817 · CCD Endocam Office 5510 · Richard Wolf Medical Instruments Corp. · 19940
  1. Root · 3 generations backK942817 CCD Endocam Office 5510Richard Wolf Medical Instruments Corp. · 1994
  2. 2 generations backK982965 Endocam Camera Systems 5502/5507 with CR Camera Heads and AccessoriesRichard Wolf Medical Instruments Corp. · 1998
  3. 1 generation backK023659 1-CCD Endocam 5520 SystemRichard Wolf Medical Instruments Corp. · 2003
  4. This deviceK080809 Iec Medsight and MedbrightInnovative Endoscopy Components, LLC · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K942817CCD Endocam Office 5510Richard Wolf Medical Instruments Corp.1994—
−2K982965Endocam Camera Systems 5502/5507 with CR Camera Heads and AccessoriesRichard Wolf Medical Instruments Corp.1998—
−1K0236591-CCD Endocam 5520 SystemRichard Wolf Medical Instruments Corp.2003—
0 (this device)K080809Iec Medsight and MedbrightInnovative Endoscopy Components, LLC2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199110
199410
199530
199620
199830
199910
200010
200120
200310
200710
FIG. 1 — Lineage of K080809, 1994–2008Source: 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? (10)

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
*K974391Karl Storz Endovision XL Endoscopic Camera System
Summary page 2
…onnects to the endoscope. All these components are designed, constructed and intended to be operated exclusively as a unit. 6. Substantial Equivalence: K974391, Karl Storz Imaging Endovision XL Endoscopic Camera K983279, Richard Wolf 1CCD Endocam K023659, Richard Wolf 1CCD Endoc…
Karl Storz Imaging, Inc.1998—
*K983279Endocam Camera Systems 5502 with Electronic CCD Endoscope
Summary page 2
…ed, constructed and intended to be operated exclusively as a unit. 6. Substantial Equivalence: K974391, Karl Storz Imaging Endovision XL Endoscopic Camera K983279, Richard Wolf 1CCD Endocam K023659, Richard Wolf 1CCD Endocam K003325, KSI NCA Video Imaging System K983566, Stryk…
Richard Wolf Medical Instruments Corp.1998—
*K0236591-CCD Endocam 5520 System
Summary page 2
…ted exclusively as a unit. 6. Substantial Equivalence: K974391, Karl Storz Imaging Endovision XL Endoscopic Camera K983279, Richard Wolf 1CCD Endocam K023659, Richard Wolf 1CCD Endocam K003325, KSI NCA Video Imaging System K983566, Stryker 888 Video Camera K994090, KSI Au…
Richard Wolf Medical Instruments Corp.2003—
*K003325Ksi's New Camera Architecture (Nca) Video Imaging System
Summary page 2
…antial Equivalence: K974391, Karl Storz Imaging Endovision XL Endoscopic Camera K983279, Richard Wolf 1CCD Endocam K023659, Richard Wolf 1CCD Endocam K003325, KSI NCA Video Imaging System K983566, Stryker 888 Video Camera K994090, KSI Autoclavable Camera Head K070266, Smi…
Karl Storz Imaging, Inc.2001—
*K9835663-Chip Video Camera
Summary page 2
…z Imaging Endovision XL Endoscopic Camera K983279, Richard Wolf 1CCD Endocam K023659, Richard Wolf 1CCD Endocam K003325, KSI NCA Video Imaging System K983566, Stryker 888 Video Camera K994090, KSI Autoclavable Camera Head K070266, Smith & Nephew 560 HD Camera System K962…
Stryker Endoscopy19991
*K994090Karl Storz Autoclavable Camera Head
Summary page 2
…ra K983279, Richard Wolf 1CCD Endocam K023659, Richard Wolf 1CCD Endocam K003325, KSI NCA Video Imaging System K983566, Stryker 888 Video Camera K994090, KSI Autoclavable Camera Head K070266, Smith & Nephew 560 HD Camera System K962595, Karl Storz Xenon 300 Light Source…
Karl Storz Imaging, Inc.2000—
*K070266560 High Definition Camera System
Summary page 2
…K023659, Richard Wolf 1CCD Endocam K003325, KSI NCA Video Imaging System K983566, Stryker 888 Video Camera K994090, KSI Autoclavable Camera Head K070266, Smith & Nephew 560 HD Camera System K962595, Karl Storz Xenon 300 Light Source K983628, Richard Wolf Auto LP 5123 Xeno…
Smith & Nephew, Inc.20071
*K962595Karl Storz Xenon 300 Light Source for Non-Flash Applications
Summary page 2
…5, KSI NCA Video Imaging System K983566, Stryker 888 Video Camera K994090, KSI Autoclavable Camera Head K070266, Smith & Nephew 560 HD Camera System K962595, Karl Storz Xenon 300 Light Source K983628, Richard Wolf Auto LP 5123 Xenon Light Projector K905376, Karl Storz S6000 Lig…
KARL STORZ Endoscopy-America, Inc.1996—
*K983628Xenon Light Source Auto Lip 5123, Model 2123.011
Summary page 2
…tryker 888 Video Camera K994090, KSI Autoclavable Camera Head K070266, Smith & Nephew 560 HD Camera System K962595, Karl Storz Xenon 300 Light Source K983628, Richard Wolf Auto LP 5123 Xenon Light Projector K905376, Karl Storz S6000 Light Source 7. Description of Saf…
Richard Wolf Medical Instruments Corp.1998—
*K905376Storz S6000 Light Source
Summary page 2
…Head K070266, Smith & Nephew 560 HD Camera System K962595, Karl Storz Xenon 300 Light Source K983628, Richard Wolf Auto LP 5123 Xenon Light Projector K905376, Karl Storz S6000 Light Source 7. Description of Safety: The selection of the materials has been determined…
Storz Instrument Co.1991—

Also cleared against K974391: 2 other devices →

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 14 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
  • 2 of the 20 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K974391.

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. 2008, 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 Innovative Endoscopy Components (IEC) MedSIGHT and MedBRIGHT is a video system for endoscopes. MedSIGHT is a color, television camera system (supplies image) and MedBRIGHT is a xenon/halogen light source system (supplies light). Both can be used with all rigid endoscopes (like Arthroscopes, Cystoscopes, Hysteroscopes, Laparoscopes, Ureterorenoscopes, etc.) and some flexible endoscopes (Sinuscope and Bronchoscope) and it is designed for surgical procedures.

Indications for use as stated in the FDA summary.

Also cleared against K974391

2 other devices cite the same predicate.

  • K020336Endoscopic Camera MC404/C3World of Medicine Lemke GmbH · 2002
  • K991416Endoscopic CameraGenzyme Surgical Product (Genzyme Biosurgery) · 1999

More from Innovative Endoscopy Components, LLC

3 FDA decisions under this applicant name. See the company

  • K062707Rudolf Innoview Autoclavable Semi-Rigid Uretero-RenoscopeInnovative Endoscopy Components, LLC · 2006
  • K992983Baho Autoclavable CystoscopeInnovative Endoscopy Components, LLC · 1999

Recent decisions in FET

The FET category page

  • K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp. · 2026
  • K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation · 2026
  • K261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems Corporation · 2026
  • K251734ProVee Video Processing Unit (PV-003)Proverum Limited · 2025
  • K250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private Limited · 2025

https://510kreport.com/device/K080809 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080809: Iec Medsight and Medbright.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080809

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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