510(k) · Cleared
Recalled · 2010IR Wireless Foot Switch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linemaster Switch Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 20, 2006 as substantially equivalent to K051831 (Applied Surgical, LLC, 2005) and 4 other predicates after a 94-day review. Its family tree reaches back 8 generations to 1993. 12 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 20, 2006
- Review
- 94 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 8 generations to K931783 (1993). 22 ancestors in all, the oldest K890841 (1989). 12 later devices descend from it, 4 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 backK033135 Stryker Wireless Universal Footswitch SystemStryker Endoscopy · 2004
- This deviceK053510 IR Wireless Foot SwitchLinemaster Switch Corp. · 2006
- 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
- Descendant · 3 generations on · 1 of its ownK231126 Eblator DeviceE Surgical, LLC · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- 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
- K231126Eblator DeviceE Surgical, LLC · 2023 · 3 generations on1descendant
View 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 | K033135 | Stryker Wireless Universal Footswitch System | Stryker Endoscopy | 2004 | — |
| 0 (this device) | K053510 | IR Wireless Foot Switch | Linemaster Switch Corp. | 2006 | — |
| +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 |
| +3 | K231126 | Eblator Device | E Surgical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 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? (5)
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 |
|---|---|---|---|
| * | K051831 | Gemini Surgical Control & Display SystemSummary page 2…substantially equivalent in function and intended use to the following legally marketed devices: Applied Surgical, LLC, Gemini Surgical and Display System (K051831), Stryker wireless universal footswitch (K033135), SurgASSIST system with wireless remote control (K020343), Megady… | 2005 |
| * | K033135 | Stryker Wireless Universal Footswitch SystemSummary page 2…use to the following legally marketed devices: Applied Surgical, LLC, Gemini Surgical and Display System (K051831), Stryker wireless universal footswitch (K033135), SurgASSIST system with wireless remote control (K020343), Megadyne Mega power electrosurgical generator accessories… | 2004 |
| * | K020343 | Surgassist System; Wireless Remote Control (Component); Wired Remote ControlSummary page 2…LLC, Gemini Surgical and Display System (K051831), Stryker wireless universal footswitch (K033135), SurgASSIST system with wireless remote control (K020343), Megadyne Mega power electrosurgical generator accessories (K050579) and Valleylab force FXc accessories (K944602).… | 2002 |
| * | K050579 | Mega Power Electrosurgical GeneratorSummary page 2…universal footswitch (K033135), SurgASSIST system with wireless remote control (K020343), Megadyne Mega power electrosurgical generator accessories (K050579) and Valleylab force FXc accessories (K944602). Device Description: The Linemaster wireless foot switch will be… | 2005 |
| * | K944602 | Valleylab Force FXSummary page 2…IST system with wireless remote control (K020343), Megadyne Mega power electrosurgical generator accessories (K050579) and Valleylab force FXc accessories (K944602). Device Description: The Linemaster wireless foot switch will be an accessory to and provide foot switc… | 1995 |
What descends from it? (12)
See all 124 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 |
|---|---|---|---|---|
| Dec 21, 2010 | Not classified | Z-0939-2011 | Process control | Surgical equipment, activated by a wireless foot switch, may remain powered on when switch is no longer depressed. |
| Dec 28, 2007 | Not classified | Z-0933-2008 | Device Design | Failure to shut-off: Surgical equipment, activated by a wireless foot switch with VASER system, may remain powered on when switch is no longer depressed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 4 of the 22 ancestors have a recall of any class.
- Of its descendants, K083161 (Conmed Linvatec, 2009) has gone furthest, with 9 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Linemaster wireless foot switch is an accessory that is indicated for use to provide foot switch input control to any medical device that uses a wired foot switch with a switch closure (on/off), to activate said device.
The system is intended for use in hospitals, outpatient clinics and physicians offices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053510 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053510: IR Wireless Foot Switch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053510
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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