510(k) · Cleared
Recalled · 2011Stryker Switchpoint Infinity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Communications Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Sep 2, 2004 as substantially equivalent to K022393 (Stryker Endoscopy, 2003) and 2 other predicates after a 338-day review. Its family tree reaches back 7 generations to 1993. 8 later devices descend from it. It has been recalled 11 times.
- Decided
- Sep 2, 2004
- Review
- 338 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 11
- Predicates
- 3
Its longest line of descent runs back 7 generations to K931783 (1993). 12 ancestors in all. 8 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 6 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 5 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 4 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 3 generations backK990691 Hermes Operating Room Control CenterComputer Motion, Inc. · 1999
- 2 generations backK991444 Hermes Control Center, with Control of the Aesop 3000HR (Hermes…Computer Motion, Inc. · 1999
- 1 generation backK022393 Merdoc SystemStryker Endoscopy · 2003
- This deviceK033132 Stryker Switchpoint InfinityStryker Communications Corp. · 2004
- Descendant · cites it directly · 2 of its ownK100852 Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000Stryker Communications · 2010
- Descendant · cites it directly · 2 of its ownK070556 Brainsuite NetBrainlab AG · 2007
- Descendant · cites it directly · 1 of its ownK161122 Sony IP Converter NU-IP40SSony Electronics, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK123426 Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd. · 2013
- Descendant · cites it directly · 1 of its ownK060717 Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2006
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K100852Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000Stryker Communications · 2010 · cites it directly2descendants
- K070556Brainsuite NetBrainlab AG · 2007 · cites it directly2descendants
- K161122Sony IP Converter NU-IP40SSony Electronics, Inc. · 2016 · cites it directly1descendant
- K123426Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd. · 2013 · 2 generations on1descendant
- K060717Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2006 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −6 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −5 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −4 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −3 | K990691 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1999 | — |
| −2 | K991444 | Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready). | Computer Motion, Inc. | 1999 | — |
| −1 | K022393 | Merdoc System | Stryker Endoscopy | 2003 | — |
| 0 (this device) | K033132 | Stryker Switchpoint Infinity | Stryker Communications Corp. | 2004 | — |
| +1 | K100852 | Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000 | Stryker Communications | 2010 | — |
| +1 | K070556 | Brainsuite Net | Brainlab AG | 2007 | — |
| +1 | K161122 | Sony IP Converter NU-IP40S | Sony Electronics, Inc. | 2016 | — |
| +2 | K123426 | Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSS | Orpheus Medical, Ltd. | 2013 | — |
| +1 | K060717 | Nurse Assistant 1.7 O.R. Control System | Conmed Integrated Systems (Cmis) | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2020 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K022393 | Merdoc SystemSummary page 1…antially equivalent in safety and efficacy as the currently marketed SidneTM System and Nurse's Assistant OR Control System. The Sidne T System was cleared under 510(k)# K022393. The Nurse's Assistant OR Control System was cleared under 510(k)# K01 0754. The Switchpoint InfinityTM Control System is also su… | 2003 |
| * | K010754 | Nurse's Assistant O.R. Control SystemSummary page 1…M System and Nurse's Assistant OR Control System. The Sidne T System was cleared under 510(k)# K022393. The Nurse's Assistant OR Control System was cleared under 510(k)# K01 0754. The Switchpoint InfinityTM Control System is also substantially equivalent in reference to the teleconferencing feature to the S… | 2001 |
| * | K020640 | Ksea SCB Media ControlSummary page 1…the Stryker Switchpoint TM Ill, a Class I device as determined by 513(g) #C040069, and the KSEA Storz Communication Bus (SCB) Media ControlTM already cleared in 510(k) #K020640. Indications for Use: The Switchpoint InfinityTM Control System is a medical device that is designed to allow direct control of t… | 2002 |
| * | — | Stryker Switchpoint III Named without a submission number |
What descends from it? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 23, 2011 | Not classified | Z-0138-2012 | Process control | Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate. |
| Apr 30, 2010 | Not classified | Z-1803-2010 | Component design/selection | Users may experience issues with the functionality of the SwitchPoint Infinity 2 and SwitchPoint Element that may be exhibited as a "Page Not Found" error message, missing drop down options, or a frozen touch panel. |
| Apr 15, 2010 | Not classified | Z-1641-2010 | Employee error | Installation records are incomplete. |
| Apr 15, 2010 | Not classified | Z-1643-2010 | Employee error | Installation records are incomplete. |
| Apr 15, 2010 | Not classified | Z-1640-2010 | Employee error | Installation records are incomplete. |
| Apr 15, 2010 | Not classified | Z-1645-2010 | Employee error | Installation records are incomplete. |
| Apr 15, 2010 | Not classified | Z-1642-2010 | Employee error | Installation records are incomplete. |
| Apr 15, 2010 | Not classified | Z-1644-2010 | Employee error | Installation records are incomplete. |
| Apr 1, 2008 | Not classified | Z-2467-2008 | Process control | Product at times experiences intermittent signal loss due to electromagnetic interference. |
| Oct 3, 2007 | Not classified | Z-0302-2008 | Nonconforming Material/Component | Intermitten or Complete Loss of Signal: out-of-specification DVI cables causing intermitten or complete loss of signal on monitors used in surgery. |
| Oct 3, 2007 | Not classified | Z-0303-2008 | Nonconforming Material/Component | Intermitten or Complete Loss of Signal: out-of-specification DVI cables causing intermitten or complete loss of signal on monitors used in surgery. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K100852 (Stryker Communications, 2010) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K022393.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The Switchpoint InfinityTM Control System is a medical device that is designed to allow direct control of the state, selection, and settings of room equipment, and audio/video equipment and indirect control through the Stryker Endoscopy SidneTM System of the state, selection, and settings of surgical equipment in the operating room. The Switchpoint Infinity TM Control System is also an integrated voice, video, and data router and teleconferencing…
Read the full statement (174 words)
The Switchpoint InfinityTM Control System is a medical device that is designed to allow direct control of the state, selection, and settings of room equipment, and audio/video equipment and indirect control through the Stryker Endoscopy SidneTM System of the state, selection, and settings of surgical equipment in the operating room. The Switchpoint Infinity TM Control System is also an integrated voice, video, and data router and teleconferencing interface for the operating room. The intent of the Switchpoint Infinity TM Control System is to allow operating room personnel a center point for controlling all equipment and communication in surgery.
The Stryker Switchpoint Infinity TM Control System is indicated for use with the Stryker Endoscopy Sidne TM System [510(k) # K022393] and SidneT M compatible endoscopic and general surgery devices. The users of Switchpoint Infinity T M Control System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, urologists, radiologists, and any other surgeon whom requires the use of voice, video, or control in the operating room or a teleconferencing interface.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033132 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033132: Stryker Switchpoint Infinity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033132
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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