510(k) · Cleared
ClearedIDSS ForceTriad Control Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Black Diamond Video, Inc. · ODA Endoscopic Central Control Unit
Cleared on Aug 1, 2016 as substantially equivalent to K111165 (KARL STORZ Endoscopy-America, Inc., 2012) after a 271-day review. Its family tree reaches back 2 generations to 2008.
- Decided
- Aug 1, 2016
- Review
- 271 days
- Class
- Class II
- Product code
- ODA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K080410 (2008). No later device cites it as a predicate yet.
- Root · 2 generations backK080410 Karl Storz SCB/Conmed Esu Interface Module, Model 20091522KARL STORZ Endoscopy-America, Inc. · 2008
- 1 generation backK111165 Karl Storz SCB / Covidien Forcetriad Interface ModuleKARL STORZ Endoscopy-America, Inc. · 2012
- This deviceK153205 IDSS ForceTriad Control ModuleBlack Diamond Video, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K080410 | Karl Storz SCB/Conmed Esu Interface Module, Model 20091522 | KARL STORZ Endoscopy-America, Inc. | 2008 | — |
| −1 | K111165 | Karl Storz SCB / Covidien Forcetriad Interface Module | KARL STORZ Endoscopy-America, Inc. | 2012 | — |
| 0 (this device) | K153205 | IDSS ForceTriad Control Module | Black Diamond Video, Inc. | 2016 | — |
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 K203566 Tablet Applicationscore 6.7 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111165 | Karl Storz SCB / Covidien Forcetriad Interface ModuleSummary page 4…21 CFR 876.1500 Class: 2 Product Code: ODA Predicate Device : Karl Storz SCB/Covidien ForceTriad Interface Module (K111165) Device Description: The IDSS ForceTriad Control Module is an additional function to the IDSS, which is an i… | 2012 |
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 8 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All ODA devicesODA Endoscopic Central Control Unit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · ODA
1in 2023
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
MAUDE reports naming product code ODA, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IDSS-ForceTriad Control Module is designed for integration in the IDSS (Integrated Digital Surgical Suite) and enables the Covidien ForceTriad Energy Platform to be controlled remotely.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153205 · printed Nov 4, 2026
Cite this page
510(k) Report. “K153205: IDSS ForceTriad Control Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K153205
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