510(k) · Cleared
ClearedVisiclear Smoke Evacuation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Buffalo Filter Co., Inc. · FYD Apparatus, Exhaust, Surgical
Cleared on Mar 3, 2014 as substantially equivalent to K091139 (Conmed Corporation, 2009) and 1 other predicate after a 292-day review. Its family tree reaches back 3 generations to 1993. 4 later devices descend from it.
- Decided
- Mar 3, 2014
- Review
- 292 days
- Class
- Class II
- Product code
- FYD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K924732 (1993). 4 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK924732 Porta Plumesafe (TM) 601 Smoke Evacuation SystemBuffalo Filter Co., Inc. · 1993
- 2 generations backK053464 Service Manager SM40SEConmed Integrated Systems, Canada, Ulc · 2006
- 1 generation backK091139 Conmed Aer Defense Smoke EvacuatorConmed Corporation · 2009
- This deviceK131402 Visiclear Smoke Evacuation SystemBuffalo Filter Co., Inc. · 2014
- Descendant · cites it directly · 0 of its ownK240127 PlumeSafe X5 Smoke Management SystemConmed Corporation · 2024
- Descendant · cites it directly · 0 of its ownK233789 8Q10 Surclear Smoke Plume Evacuation SystemSurnic Corporation · 2024
- Descendant · cites it directly · 0 of its ownK182224 SafeAir Smoke Evacuator compactLina Medical Aps · 2019
- Descendant · cites it directly · 0 of its ownK142335 RapidVac Smoke Evacuator SystemCovidien · 2015
Most influential descendants
Showing 4 of 4 · See all- K240127PlumeSafe X5 Smoke Management SystemConmed Corporation · 2024 · cites it directly0descendants
- K2337898Q10 Surclear Smoke Plume Evacuation SystemSurnic Corporation · 2024 · cites it directly0descendants
- K182224SafeAir Smoke Evacuator compactLina Medical Aps · 2019 · cites it directly0descendants
- K142335RapidVac Smoke Evacuator SystemCovidien · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924732 | Porta Plumesafe (TM) 601 Smoke Evacuation System | Buffalo Filter Co., Inc. | 1993 | — |
| −2 | K053464 | Service Manager SM40SE | Conmed Integrated Systems, Canada, Ulc | 2006 | — |
| −1 | K091139 | Conmed Aer Defense Smoke Evacuator | Conmed Corporation | 2009 | — |
| 0 (this device) | K131402 | Visiclear Smoke Evacuation System | Buffalo Filter Co., Inc. | 2014 | — |
| +1 | K240127 | PlumeSafe X5 Smoke Management System | Conmed Corporation | 2024 | — |
| +1 | K233789 | 8Q10 Surclear Smoke Plume Evacuation System | Surnic Corporation | 2024 | — |
| +1 | K182224 | SafeAir Smoke Evacuator compact | Lina Medical Aps | 2019 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K091139 | Conmed Aer Defense Smoke EvacuatorSummary page 2…lass It 2. Predicate DeVice Buffalo Filter, LLC ("Bufalo Filter") claims substantial equivalence to: a. Conmned Corporation. Conmed Aer Defense Smoke Evacuator (K091 139) b. Buffalo Filter. Porita PlumeSafe 601 Smoke Evacuation System (K924732) 3. Description of Device The VISICL… | 2009 |
| * | K924732 | Porta Plumesafe (TM) 601 Smoke Evacuation SystemSummary page 2…antial equivalence to: a. Conmned Corporation. Conmed Aer Defense Smoke Evacuator (K091 139) b. Buffalo Filter. Porita PlumeSafe 601 Smoke Evacuation System (K924732) 3. Description of Device The VISICLEAR smoke evacuation system is a sel f-contained system that is used to r… | 1993 |
What descends from it? (4)
4 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)
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 21 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K240127 (Conmed Corporation, 2024) has gone furthest, with 0 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. 2014, 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 VlsiClear Smoke Evacuation System is designed to remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131402 · printed Nov 4, 2026
Cite this page
510(k) Report. “K131402: Visiclear Smoke Evacuation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K131402
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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