510(k) · Cleared
ClearedStryker Switchpoint Infinity 3 Control System, Model: 067-8001-000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Communications · OCS Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on May 6, 2010 as substantially equivalent to K033132 (Stryker Communications Corp., 2004) and 2 other predicates after a 41-day review. Its family tree reaches back 8 generations to 1993. 2 later devices descend from it.
- Decided
- May 6, 2010
- Review
- 41 days
- Class
- Class II
- Product code
- OCS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K931783 (1993). 40 ancestors in all, the oldest K801623 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 7 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 6 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 5 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 4 generations backK990691 Hermes Operating Room Control CenterComputer Motion, Inc. · 1999
- 3 generations backK991444 Hermes Control Center, with Control of the Aesop 3000HR (Hermes…Computer Motion, Inc. · 1999
- 2 generations backK022393 Merdoc SystemStryker Endoscopy · 2003
- 1 generation backK033132 Stryker Switchpoint InfinityStryker Communications Corp. · 2004 · Recalled
- This deviceK100852 Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000Stryker Communications · 2010
- Descendant · cites it directly · 1 of its ownK123426 Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK151737 MedicVOD SystemOrpheus Medical, Ltd. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −7 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −6 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −5 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −4 | K990691 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1999 | — |
| −3 | K991444 | Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready). | Computer Motion, Inc. | 1999 | — |
| −2 | K022393 | Merdoc System | Stryker Endoscopy | 2003 | — |
| −1 | K033132 | Stryker Switchpoint Infinity | Stryker Communications Corp. | 2004 | 11 |
| 0 (this device) | K100852 | Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000 | Stryker Communications | 2010 | — |
| +1 | K123426 | Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSS | Orpheus Medical, Ltd. | 2013 | — |
| +2 | K151737 | MedicVOD System | Orpheus Medical, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 8 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 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 OCS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033132 | Stryker Switchpoint InfinitySummary page 5…based on similarities in intended uses, design and operational principles to the following substantially equivalent devices: Stryker SwitchPoint Infinity Control System (K033132), Olympus EndoALPHA Integrated Endosurgery System (K051613), and KSEA Storz Communication Bus (SCB) Media Control (K020640). The… | 2004 |
| * | K051613 | Modification to Olympus Integrated Endosurgery System Endoalpha (Control Unit for…Summary page 5…nal principles to the following substantially equivalent devices: Stryker SwitchPoint Infinity Control System (K033132), Olympus EndoALPHA Integrated Endosurgery System (K051613), and KSEA Storz Communication Bus (SCB) Media Control (K020640). The minor differences between the Stryker SwitchPoint infinity®… | 2005 |
| * | K020640 | Ksea SCB Media ControlSummary page 5…: Stryker SwitchPoint Infinity Control System (K033132), Olympus EndoALPHA Integrated Endosurgery System (K051613), and KSEA Storz Communication Bus (SCB) Media Control (K020640). The minor differences between the Stryker SwitchPoint infinity® 3 Control System and the predicate device raise no new issues o… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123426 | Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSS | 2013 | 1 |
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 17 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 40 ancestors has a recall of any class.
- Of its descendants, K123426 (Orpheus Medical, Ltd., 2013) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K033132.
How does its category compare?
All OCS devicesOCS Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OCS
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · OCS
Too few OCS 510(k)s in any year since 2007 to give a median.
Recalls per year · OCS
No recall names OCS since 2007.
Adverse event reports per year · OCS
2in 2021
MAUDE reports naming product code OCS, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Stryker SwitchPoint Infinity® 3 Control System is intended to be a central point of
control and integration of ancillary compatible equipment, audio, video, and data
routing, as well as teleconferencing for medical personnel.
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/K100852 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100852: Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100852
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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