510(k) · Cleared
ClearedPlumeSafe X5 Smoke Management System
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 Aug 5, 2024 as substantially equivalent to K131402 (Buffalo Filter Co., Inc., 2014) after a 201-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Aug 5, 2024
- Review
- 201 days
- Class
- Class II
- Product code
- FYD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K924732 (1993). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK924732 Porta Plumesafe (TM) 601 Smoke Evacuation SystemBuffalo Filter Co., Inc. · 1993
- 3 generations backK053464 Service Manager SM40SEConmed Integrated Systems, Canada, Ulc · 2006
- 2 generations backK091139 Conmed Aer Defense Smoke EvacuatorConmed Corporation · 2009
- 1 generation backK131402 Visiclear Smoke Evacuation SystemBuffalo Filter Co., Inc. · 2014
- This deviceK240127 PlumeSafe X5 Smoke Management SystemConmed Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924732 | Porta Plumesafe (TM) 601 Smoke Evacuation System | Buffalo Filter Co., Inc. | 1993 | — |
| −3 | K053464 | Service Manager SM40SE | Conmed Integrated Systems, Canada, Ulc | 2006 | — |
| −2 | K091139 | Conmed Aer Defense Smoke Evacuator | Conmed Corporation | 2009 | — |
| −1 | K131402 | Visiclear Smoke Evacuation System | Buffalo Filter Co., Inc. | 2014 | — |
| 0 (this device) | K240127 | PlumeSafe X5 Smoke Management System | Conmed Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 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 K233789 8Q10 Surclear Smoke Plume Evacuation Systemscore 8.1 · 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 |
|---|---|---|---|
| * | K131402 | Visiclear Smoke Evacuation SystemSummary page 5…Trade Name: VisiClear Smoke Evacuation Unit Company Name: CONMED 510(k): K131402 IV. DEVICE DESCRIPTION The PlumeSafe® X5™ Smoke Management System is a portable, stand-alone, capital unit, tha… | 2014 |
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 31 years and passes through 3 companies; a new generation was cleared every 10.4 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K131402.
How does its category compare?
All FYD devicesFYD Apparatus, Exhaust, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 PlumeSafe® X5 TM Smoke Management 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/K240127 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240127: PlumeSafe X5 Smoke Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240127
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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