510(k) · Cleared
ClearedPorta Plumesafe (TM) 601 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 Sep 13, 1993 after a 356-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.
- Decided
- Sep 13, 1993
- Review
- 356 days
- Class
- Class II
- Product code
- FYD
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 4 citing it directly.
- This deviceK924732 Porta Plumesafe (TM) 601 Smoke Evacuation SystemBuffalo Filter Co., Inc. · 1993
- Descendant · cites it directly · 6 of its ownK053464 Service Manager SM40SEConmed Integrated Systems, Canada, Ulc · 2006
- Descendant · cites it directly · 5 of its ownK091139 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K053464Service Manager SM40SEConmed Integrated Systems, Canada, Ulc · 2006 · cites it directly6descendants
- K091139Conmed Aer Defense Smoke EvacuatorConmed Corporation · 2009 · cites it directly5descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924732 | Porta Plumesafe (TM) 601 Smoke Evacuation System | Buffalo Filter Co., Inc. | 1993 | — |
| +1 | K053464 | Service Manager SM40SE | Conmed Integrated Systems, Canada, Ulc | 2006 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (8)
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?
- Of its descendants, K053464 (Conmed Integrated Systems, Canada, Ulc, 2006) has gone furthest, with 6 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 | — |
https://510kreport.com/device/K924732 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924732: Porta Plumesafe (TM) 601 Smoke Evacuation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924732
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026