510(k) · Cleared
ClearedSafeAir Smoke Evacuator compact
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lina Medical Aps · FYD Apparatus, Exhaust, Surgical
Cleared on Feb 7, 2019 as substantially equivalent to K131402 (Buffalo Filter Co., Inc., 2014) after a 175-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Feb 7, 2019
- Review
- 175 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 deviceK182224 SafeAir Smoke Evacuator compactLina Medical Aps · 2019
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) | 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 |
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? (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 4…D Panel: General and Plastic Surgery Devices Regulation Number: 21CFR 878.5070 Predicate Device: Visiclear Smoke Evacuation System – K131402 Device Description SafeAir Smoke Evacuator compact is a device with a vacuum pump that aspirates and filtrates the surgical smok… | 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 26 years and passes through 4 companies; a new generation was cleared every 4.9 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. 2019, 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?
SafeAir Smoke Evacuator compact is designed to remove and filter smoke generated during electrosurgical and laser procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182224: SafeAir Smoke Evacuator compact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182224
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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