510(k) Report

510(k) · Cleared

Cleared

Karl Storz SCB / Covidien Forcetriad Interface Module

K111165510(k) SpecialCleared Jan 6, 2012255-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

KARL STORZ Endoscopy-America, Inc. · ODA Endoscopic Central Control Unit

Cleared on Jan 6, 2012 as substantially equivalent to K080410 (KARL STORZ Endoscopy-America, Inc., 2008) after a 255-day review. Its family tree reaches back 1 generation to 2008. 1 later device descends from it.

Decided
Jan 6, 2012
Review
255 days
Class
Class II
Product code
ODA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K080410 (2008). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2016: 1 descendant clearedK080410 · Karl Storz SCB/Conmed Esu Interface Module, Model 20091522 · KARL STORZ Endoscopy-America, Inc. · 200820052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K080410 · Karl Storz SCB/Conmed Esu Interface Module, Model 20091522 · KARL STORZ Endoscopy-America, Inc. · 20080
  1. Root · 1 generation backK080410 Karl Storz SCB/Conmed Esu Interface Module, Model 20091522KARL STORZ Endoscopy-America, Inc. · 2008
  2. This deviceK111165 Karl Storz SCB / Covidien Forcetriad Interface ModuleKARL STORZ Endoscopy-America, Inc. · 2012
  3. Descendant · cites it directly · 0 of its ownK153205 IDSS ForceTriad Control ModuleBlack Diamond Video, Inc. · 2016

Most influential descendants

Showing 1 of 1 · See all
  • K153205IDSS ForceTriad Control ModuleBlack Diamond Video, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K080410Karl Storz SCB/Conmed Esu Interface Module, Model 20091522KARL STORZ Endoscopy-America, Inc.2008—
0 (this device)K111165Karl Storz SCB / Covidien Forcetriad Interface ModuleKARL STORZ Endoscopy-America, Inc.2012—
+1K153205IDSS ForceTriad Control ModuleBlack Diamond Video, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
FIG. 1 — Lineage of K111165, 2008–2016Source: 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 ODA? 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 ODA device

  1. #1 K203566 Tablet Applicationscore 6.7 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K080410Karl Storz SCB/Conmed Esu Interface Module, Model 20091522
Summary page 1
…ssification Name: Endoscopic central control unit Regulation Number; 21 CFR 876.1500 Product Code: ODA Predicate Device(s): Karl Storz SCB/ConMed ESU Interface Module (K080410) Device Description: The Kar Storz SCB/Covidien ForceTriad Interface Module is an accessory to integrate the third party device…
KARL STORZ Endoscopy-America, Inc.2008—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K153205IDSS ForceTriad Control ModuleBlack Diamond Video, Inc.20160

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?

  • Its one ancestor has no recall.
  • Of its descendants, K153205 (Black Diamond Video, Inc., 2016) has gone furthest, with 0 descendants of its own.

How does its category compare?

All ODA devices

ODA Endoscopic Central Control Unit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · ODA

1in 2023

2007: 12008: 12009: 12010: 12011: 12012: 12016: 22020: 12021: 12022: 12023: 1
2007high 2 (2016) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODA

Too few ODA 510(k)s in any year since 2007 to give a median.

Recalls per year · ODA

No recall names ODA since 2007.

Adverse event reports per year · ODA

3in 2025

2009: 22010: 12011: 22012: 12015: 12017: 12025: 3
2007high 3 (2025) · low 0 (2007)2025

MAUDE reports naming product code ODA, 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—00
20081—00
20091—02
20101—01
20111—02
20121—01
20130—00
20140—00
20150—01
20162—00
20170—01
20180—00
20190—00
20201—00
20211—00
20221—00
20231—00
20240—00
20250—03
20260—0—

What is it indicated for?

The KARL STORZ SCB/Covidien ForceTriad Interface Module is designed for integration in the SCB Interface Control, SCB Media Control or ACC Control and enables the COVIDIEN ForceTriad Energy Platform to be controlled remotely with the KARL STORZ SCB control NEO system.

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. “K111165: Karl Storz SCB / Covidien Forcetriad Interface Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111165

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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