510(k) · Cleared
ClearedZen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Linvatec · HRX Arthroscope
Cleared on Mar 27, 2009 as substantially equivalent to K990524 (Linvatec Corp., 1999) and 2 other predicates after a 151-day review. Its family tree reaches back 9 generations to 1993. 9 later devices descend from it.
- Decided
- Mar 27, 2009
- Review
- 151 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K931783 (1993). 39 ancestors in all, the oldest K852143 (1985). 9 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 5 generations between
- 3 generations backK022393 Merdoc SystemStryker Endoscopy · 2003
- 2 generations backK033135 Stryker Wireless Universal Footswitch SystemStryker Endoscopy · 2004
- 1 generation backK053510 IR Wireless Foot SwitchLinemaster Switch Corp. · 2006 · Recalled
- This deviceK083161 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
- Descendant · 4 generations on · 0 of its ownK251899 E BlatorNew Deantronics Taiwan, Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 8 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 7 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 6 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 5 generations backK990691 Hermes Operating Room Control CenterComputer Motion, Inc. · 1999
- 4 generations backK991444 Hermes Control Center, with Control of the Aesop 3000HR (Hermes…Computer Motion, Inc. · 1999
- 3 generations backK022393 Merdoc SystemStryker Endoscopy · 2003
- 2 generations backK033135 Stryker Wireless Universal Footswitch SystemStryker Endoscopy · 2004
- 1 generation backK053510 IR Wireless Foot SwitchLinemaster Switch Corp. · 2006 · Recalled
- This deviceK083161 Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter…Conmed Linvatec · 2009
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- 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
- K251899E BlatorNew Deantronics Taiwan, Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −8 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −7 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −6 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −5 | K990691 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1999 | — |
| −4 | K991444 | Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready). | Computer Motion, Inc. | 1999 | — |
| −3 | K022393 | Merdoc System | Stryker Endoscopy | 2003 | — |
| −2 | K033135 | Stryker Wireless Universal Footswitch System | Stryker Endoscopy | 2004 | — |
| −1 | K053510 | IR Wireless Foot Switch | Linemaster Switch Corp. | 2006 | 2 |
| 0 (this device) | 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 | — |
| +4 | K251899 | E Blator | New Deantronics Taiwan, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 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 |
|---|---|---|---|
| * | K990524 | E9000 SystemSummary page 1…Class II Product Code: HRX D. Predicate/Legally Marketed Devices ConMed Linvatec 3-Pedal 510(k) # K990524 ConMed Linvatec Footswitch Stryker Wireless Universal 510(k) # K033135… | 1999 |
| * | K033135 | Stryker Wireless Universal Footswitch SystemSummary page 1…ec 3-Pedal 510(k) # K990524 ConMed Linvatec Footswitch Stryker Wireless Universal 510(k) # K033135 Stryker Endoscopy Foot… | 2004 |
| * | K053510 | IR Wireless Foot SwitchSummary page 1…Footswitch System IR Wireless Footswitch System 510(k) # K053510 Linemaster Switch Corp… | 2006 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100638 | Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214 | 2010 | 8 |
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 16 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 7 of the 39 ancestors have a recall of any class.
- Of its descendants, K100638 (Depuy Mitek, A Johnson & Johnson Company, 2010) has gone furthest, with 8 descendants of its own.
- 10 other devices also cite its predicate K990524.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The ConMed Linvatec Zen TM Wireless Footswitch and Adapter is an accessory that is intended to interface with compatible ConMed Linvatec power drive consoles to selectively control ConMed Linvatec surgical instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083161: Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083161
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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