510(k) · Cleared
ClearedConmed Aer Defense Smoke Evacuator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Corporation · FYD Apparatus, Exhaust, Surgical
Cleared on May 5, 2009 as substantially equivalent to K924732 (Buffalo Filter Co., Inc., 1993) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 1993. 5 later devices descend from it.
- Decided
- May 5, 2009
- Review
- 15 days
- Class
- Class II
- Product code
- FYD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K924732 (1993). 3 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK924732 Porta Plumesafe (TM) 601 Smoke Evacuation SystemBuffalo Filter Co., Inc. · 1993
- 1 generation backK053464 Service Manager SM40SEConmed Integrated Systems, Canada, Ulc · 2006
- This deviceK091139 Conmed Aer Defense Smoke EvacuatorConmed Corporation · 2009
- Descendant · cites it directly · 4 of its ownK131402 Visiclear Smoke Evacuation SystemBuffalo Filter Co., Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK240127 PlumeSafe X5 Smoke Management SystemConmed Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK233789 8Q10 Surclear Smoke Plume Evacuation SystemSurnic Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK182224 SafeAir Smoke Evacuator compactLina Medical Aps · 2019
- Descendant · 2 generations on · 0 of its ownK142335 RapidVac Smoke Evacuator SystemCovidien · 2015
Most influential descendants
Showing 5 of 5 · See all- K131402Visiclear Smoke Evacuation SystemBuffalo Filter Co., Inc. · 2014 · cites it directly4descendants
- K240127PlumeSafe X5 Smoke Management SystemConmed Corporation · 2024 · 2 generations on0descendants
- K2337898Q10 Surclear Smoke Plume Evacuation SystemSurnic Corporation · 2024 · 2 generations on0descendants
- K182224SafeAir Smoke Evacuator compactLina Medical Aps · 2019 · 2 generations on0descendants
- K142335RapidVac Smoke Evacuator SystemCovidien · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924732 | Porta Plumesafe (TM) 601 Smoke Evacuation System | Buffalo Filter Co., Inc. | 1993 | — |
| −1 | K053464 | Service Manager SM40SE | Conmed Integrated Systems, Canada, Ulc | 2006 | — |
| 0 (this device) | K091139 | Conmed Aer Defense Smoke Evacuator | Conmed Corporation | 2009 | — |
| +1 | K131402 | Visiclear Smoke Evacuation System | Buffalo Filter Co., Inc. | 2014 | — |
| +2 | K240127 | PlumeSafe X5 Smoke Management System | Conmed Corporation | 2024 | — |
| +2 | K233789 | 8Q10 Surclear Smoke Plume Evacuation System | Surnic Corporation | 2024 | — |
| +2 | K182224 | SafeAir Smoke Evacuator compact | Lina Medical Aps | 2019 | — |
| +2 | K142335 | RapidVac Smoke Evacuator System | Covidien | 2015 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K924732 | Porta Plumesafe (TM) 601 Smoke Evacuation SystemSummary page 1…FYD Predicate Device: This product is similar in design, composition, and function to the Porta PlumesaferM 601 Smoke Evacuation System, K924732 and the Smoke Evacuation section of the ConMed Integrated Service Manager SM40SE, K… | 1993 |
| * | K053464 | Service Manager SM40SESummary page 1…ferM 601 Smoke Evacuation System, K924732 and the Smoke Evacuation section of the ConMed Integrated Service Manager SM40SE, K053464. Technological Characteristics Smoke Evacuator: The CONMED Aer DefenseTM Smoke Evacuator has been designed with a high suction… | 2006 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131402 | Visiclear Smoke Evacuation System | 2014 | 4 |
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 3 companies; a new generation was cleared every 12.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K131402 (Buffalo Filter Co., Inc., 2014) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K924732.
How does its category compare?
All FYD devicesFYD Apparatus, Exhaust, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 CONMED Aer Defense Smoke Evacuator is designed to remove smoke, aerosols and mitigate odors produced by surgical smoke during electrosurgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091139 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091139: Conmed Aer Defense Smoke Evacuator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091139
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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