510(k) · Cleared
ClearedSun Medical Smoke/Fluid Evac Syst, Model Sfe-200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sun Medical, Inc. · FYD Apparatus, Exhaust, Surgical
Cleared on Jul 26, 1991 after a 133-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 53 later devices descend from it.
- Decided
- Jul 26, 1991
- Review
- 133 days
- Class
- Class II
- Product code
- FYD
- Recalls
- None
- Predicates
- 0
53 later devices descend from it, 2 citing it directly.
- This deviceK911154 Sun Medical Smoke/Fluid Evac Syst, Model Sfe-200Sun Medical, Inc. · 1991
- Descendant · cites it directly · 51 of its ownK083211 Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 2008
- Descendant · cites it directly · 36 of its ownK071571 Surgiquest Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 2007
- Descendant · 2 generations on · 35 of its ownK103692 Sugiquest Airsealoptical Trocar & Cannula System with Integrated…Surgiquest, Inc. · 2011
- Descendant · 3 generations on · 27 of its ownK143404 SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015 · Recalled
- Descendant · 4 generations on · 17 of its ownK170784 PneumoclearW.O.M. World of Medicine GmbH · 2017 · Recalled
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K083211Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 2008 · cites it directly51descendants
- K071571Surgiquest Airseal Optical Trocar & Cannula SystemSurgiquest, Inc. · 2007 · cites it directly36descendants
- K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc. · 2011 · 2 generations on35descendants
- K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015 · 3 generations on27descendants
- K170784PneumoclearW.O.M. World of Medicine GmbH · 2017 · 4 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911154 | Sun Medical Smoke/Fluid Evac Syst, Model Sfe-200 | Sun Medical, Inc. | 1991 | — |
| +1 | K083211 | Airseal Optical Trocar & Cannula System | Surgiquest, Inc. | 2008 | — |
| +1 | K071571 | Surgiquest Airseal Optical Trocar & Cannula System | Surgiquest, Inc. | 2007 | — |
| +2 | K103692 | Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator… | Surgiquest, Inc. | 2011 | — |
| +3 | K143404 | SurgiQuest AirSeal iFS System | Surgiquest, Inc. | 2015 | 11 |
| +4 | K170784 | Pneumoclear | W.O.M. World of Medicine GmbH | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 8 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (53)
See all 532 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, K083211 (Surgiquest, Inc., 2008) has gone furthest, with 51 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/K911154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K911154: Sun Medical Smoke/Fluid Evac Syst, Model Sfe-200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911154
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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