510(k) · Cleared
ClearedMegadyne Foot Switch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Megadyne Medical Products, Inc. · FYD Apparatus, Exhaust, Surgical
Cleared on Jul 26, 2019 as substantially equivalent to K053510 (Linemaster Switch Corp., 2006) after a 71-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- Jul 26, 2019
- Review
- 71 days
- Class
- Class II
- Product code
- FYD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K931783 (1993). 23 ancestors in all, the oldest K890841 (1989). No later device cites it as a predicate yet.
- 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 deviceK191328 Megadyne Foot SwitchMegadyne Medical Products, Inc. · 2019
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 deviceK191328 Megadyne Foot SwitchMegadyne Medical Products, Inc. · 2019
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) | K191328 | Megadyne Foot Switch | Megadyne Medical Products, Inc. | 2019 | — |
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 |
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 FYD? 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 FYD device
- #1 K240127 PlumeSafe X5 Smoke Management Systemscore 8.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K053510 | IR Wireless Foot SwitchSummary page 4…ir-handling apparatus for surgical operating room (21 CFR 878.5070, Product Code FYD) Regulatory Class Class II Predicate Devices IR Wireless Foot Switch cleared under K053510 on March 20, 2006 Device Description The Megadyne Foot Switch is used with a compatible smoke evaluation system to control on/of… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 23 ancestors have a recall of any class.
- 3 other devices also cite its predicate K053510.
How does its category compare?
All FYD devicesFYD Apparatus, Exhaust, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · FYD
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FYD
71in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FYD
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FYD
15in 2025
MAUDE reports naming product code FYD, 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 | 3 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 1 | 39 |
| 2011 | 0 | — | 0 | 150 |
| 2012 | 0 | — | 0 | 120 |
| 2013 | 0 | — | 0 | 142 |
| 2014 | 1 | — | 0 | 71 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 3 | 71 | 0 | 11 |
| 2020 | 1 | — | 0 | 11 |
| 2021 | 1 | — | 0 | 20 |
| 2022 | 1 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 2 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 15 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
The Megadyne Foot Switch is an accessory that is intended to interface with compatible smoke evacuation systems to control on/off inputs for manual operation.
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/K191328 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191328: Megadyne 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/K191328
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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