510(k) · Cleared
ClearedStryker Wireless Universal Footswitch System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Aug 9, 2004 as substantially equivalent to K022393 (Stryker Endoscopy, 2003) and 2 other predicates after a 314-day review. Its family tree reaches back 7 generations to 1993. 13 later devices descend from it.
- Decided
- Aug 9, 2004
- Review
- 314 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K931783 (1993). 12 ancestors in all. 13 later devices descend from it, 4 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 deviceK033135 Stryker Wireless Universal Footswitch SystemStryker Endoscopy · 2004
- Descendant · cites it directly · 12 of its ownK053510 IR Wireless Foot SwitchLinemaster Switch Corp. · 2006 · Recalled
- Descendant · cites it directly · 9 of its ownK083161 Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter…Conmed Linvatec · 2009
- Descendant · cites it directly · 8 of its ownK100638 Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless…Depuy Mitek, A Johnson & Johnson Company · 2010
- Descendant · 2 generations on · 3 of its ownK152777 Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · Recalled
- Descendant · 3 generations on · 2 of its ownK161558 Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and…Bovie Medical Corporation · 2016 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K053510IR Wireless Foot SwitchLinemaster Switch Corp. · 2006 · cites it directly12descendants
- K083161Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100)Conmed Linvatec · 2009 · cites it directly9descendants
- K100638Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214Depuy Mitek, A Johnson & Johnson Company · 2010 · cites it directly8descendants
- K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · 2 generations on3descendants
- K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation · 2016 · 3 generations on2descendants
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) | K033135 | Stryker Wireless Universal Footswitch System | Stryker Endoscopy | 2004 | — |
| +1 | K053510 | IR Wireless Foot Switch | Linemaster Switch Corp. | 2006 | 2 |
| +1 | K083161 | Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100) | Conmed Linvatec | 2009 | — |
| +1 | K100638 | Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch… | Depuy Mitek, A Johnson & Johnson Company | 2010 | — |
| +2 | K152777 | Bovie Disposable Bipolar Ablator | Bovie Medical Corporation | 2016 | 2 |
| +3 | K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating… | Bovie Medical Corporation | 2016 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 KNS? 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 KNS device
- #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K022393 | Merdoc SystemSummary page 1…The Stryker Wireless Universal Footswitch System (SWUFS) is substantially equivalent in safety and efficacy as the currently marketed Stryker Sidne T MSystem (K022393), Stryker SERFAS System (K991960), and Stryker Total Performance System (K991703). The Stryker Wireless Universal Foot… | 2003 |
| * | K991960 | Serfas, Serfas Generator, Serfas Console, Serfas Probe, Serfas Handpiece Cable, Serfas…Summary page 1…ootswitch System (SWUFS) is substantially equivalent in safety and efficacy as the currently marketed Stryker Sidne T MSystem (K022393), Stryker SERFAS System (K991960), and Stryker Total Performance System (K991703). The Stryker Wireless Universal Footswitch System (SWUFS) is indicated for… | 1999 |
| * | K991703 | Stryker Hermes-Ready Total Performance SystemSummary page 1…lent in safety and efficacy as the currently marketed Stryker Sidne T MSystem (K022393), Stryker SERFAS System (K991960), and Stryker Total Performance System (K991703). The Stryker Wireless Universal Footswitch System (SWUFS) is indicated for use with compatible endoscopic and general… | 1999 |
What descends from it? (13)
See all 134 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)
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 11 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K053510 (Linemaster Switch Corp., 2006) has gone furthest, with 12 descendants of its own.
- 3 other devices also cite its predicate K022393.
How does its category compare?
All KNS devicesKNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNS
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNS
14in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNS
1,504in 2025
MAUDE reports naming product code KNS, 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 | — | 3 | 164 |
| 2008 | 3 | 61 | 5 | 587 |
| 2009 | 3 | 212 | 2 | 1,027 |
| 2010 | 4 | 168 | 0 | 908 |
| 2011 | 1 | — | 2 | 860 |
| 2012 | 2 | — | 0 | 848 |
| 2013 | 2 | — | 0 | 449 |
| 2014 | 1 | — | 0 | 405 |
| 2015 | 3 | 252 | 0 | 406 |
| 2016 | 3 | 30 | 6 | 457 |
| 2017 | 3 | 48 | 1 | 446 |
| 2018 | 5 | 62 | 0 | 563 |
| 2019 | 7 | 66 | 0 | 668 |
| 2020 | 4 | 212 | 0 | 906 |
| 2021 | 4 | 139 | 41 | 814 |
| 2022 | 3 | 182 | 0 | 913 |
| 2023 | 9 | 83 | 0 | 976 |
| 2024 | 3 | 198 | 14 | 1,533 |
| 2025 | 11 | 171 | 0 | 1,504 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
The Stryker Wireless Universal Footswitch System (SWUFS) is indicated for use with compatible endoscopic and general surgery devices. It will utilize a single footswitch to selectively control multiple devices, which typically each have their own dedicated footswitch. The system includes a wireless footswitch and receiver. The SWUFS will be an accessory to and provide footswitch input control for the Stryker Total Performance System, the SERFAS (Stryker Endoscopy Radio Frequency Ablation System) consoles, and the Valleylab Electrosurgical Generator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033135 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033135: Stryker Wireless Universal Footswitch System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033135
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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