510(k) · Cleared
ClearedService Manager SM40SE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Integrated Systems, Canada, Ulc · FYD Apparatus, Exhaust, Surgical
Cleared on Jun 6, 2006 as substantially equivalent to K955750 (Berchtold Holding GmbH, 1996) and 1 other predicate after a 175-day review. Its family tree reaches back 1 generation to 1993. 6 later devices descend from it.
- Decided
- Jun 6, 2006
- Review
- 175 days
- Class
- Class II
- Product code
- FYD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K924732 (1993). 2 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK924732 Porta Plumesafe (TM) 601 Smoke Evacuation SystemBuffalo Filter Co., Inc. · 1993
- This deviceK053464 Service Manager SM40SEConmed Integrated Systems, Canada, Ulc · 2006
- Descendant · cites it directly · 5 of its ownK091139 Conmed Aer Defense Smoke EvacuatorConmed Corporation · 2009
- Descendant · 2 generations on · 4 of its ownK131402 Visiclear Smoke Evacuation SystemBuffalo Filter Co., Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK240127 PlumeSafe X5 Smoke Management SystemConmed Corporation · 2024
- Descendant · 3 generations on · 0 of its ownK233789 8Q10 Surclear Smoke Plume Evacuation SystemSurnic Corporation · 2024
- Descendant · 3 generations on · 0 of its ownK182224 SafeAir Smoke Evacuator compactLina Medical Aps · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K091139Conmed Aer Defense Smoke EvacuatorConmed Corporation · 2009 · cites it directly5descendants
- K131402Visiclear Smoke Evacuation SystemBuffalo Filter Co., Inc. · 2014 · 2 generations on4descendants
- K240127PlumeSafe X5 Smoke Management SystemConmed Corporation · 2024 · 3 generations on0descendants
- K2337898Q10 Surclear Smoke Plume Evacuation SystemSurnic Corporation · 2024 · 3 generations on0descendants
- K182224SafeAir Smoke Evacuator compactLina Medical Aps · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924732 | Porta Plumesafe (TM) 601 Smoke Evacuation System | Buffalo Filter Co., Inc. | 1993 | — |
| 0 (this device) | K053464 | Service Manager SM40SE | Conmed Integrated Systems, Canada, Ulc | 2006 | — |
| +1 | K091139 | Conmed Aer Defense Smoke Evacuator | Conmed Corporation | 2009 | — |
| +2 | K131402 | Visiclear Smoke Evacuation System | Buffalo Filter Co., Inc. | 2014 | — |
| +3 | K240127 | PlumeSafe X5 Smoke Management System | Conmed Corporation | 2024 | — |
| +3 | K233789 | 8Q10 Surclear Smoke Plume Evacuation System | Surnic Corporation | 2024 | — |
| +3 | K182224 | SafeAir Smoke Evacuator compact | Lina Medical Aps | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K955750 | TeletomSummary page 1…YD Classification Classification Panel General & Plastic Surgery Regulation Number 878.5070 Predicate I Legally Marketed Devices K955750 Teletom Berchtold Holding GMBH K924732 Plumnesafe Whisper… | 1996 |
| * | K924732 | Porta Plumesafe (TM) 601 Smoke Evacuation SystemSummary page 1…Regulation Number 878.5070 Predicate I Legally Marketed Devices K955750 Teletom Berchtold Holding GMBH K924732 Plumnesafe Whisper 602- Smoke Evacuation Buffalo Filter Co., Inc. System… | 1993 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091139 | Conmed Aer Defense Smoke Evacuator | 2009 | 5 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K091139 (Conmed Corporation, 2009) has gone furthest, with 5 descendants of its own.
How does its category compare?
All FYD devicesFYD Apparatus, Exhaust, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 intended use for the SM40SE console is to position and manage devices such as medical gas, high and low voltage electrical, communication and accessories such as equipment shelves, drawers, IVpoles and smoke evacuation units.
The smoke plume evacuator integrated into the SM40SE is intended for the evacuation and filtration of smoke plume and odor generated during laser or electrosurgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053464 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053464: Service Manager SM40SE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053464
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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