510(k) · Cleared
ClearedLapevac, Filtration Device for the Periotoneum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtek Devices, Inc. · FYD Apparatus, Exhaust, Surgical
Cleared on Feb 13, 2006 after a 133-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 78 later devices descend from it.
- Decided
- Feb 13, 2006
- Review
- 133 days
- Class
- Class II
- Product code
- FYD
- Recalls
- None
- Predicates
- 1
78 later devices descend from it, 4 citing it directly.
- This deviceK052797 Lapevac, Filtration Device for the PeriotoneumMedtek Devices, Inc. · 2006
- 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 · cites it directly · 23 of its ownK062779 Defogging Heated Endoscope Lens Protector (Dhelp); Defogging…New Wave Surgical Corporation · 2006 · Recalled
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · 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
- K062779Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector…New Wave Surgical Corporation · 2006 · cites it directly23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052797 | Lapevac, Filtration Device for the Periotoneum | Medtek Devices, Inc. | 2006 | — |
| +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 |
| +1 | K062779 | Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens… | New Wave Surgical Corporation | 2006 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 7 | 0 |
| 2019 | 6 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 8 | 0 |
| 2025 | 7 | 0 |
| 2026 | 11 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K91154 | Sun Medical SFE-200 / Sun Medical Smoke Evacuator Circuit Number could not be read Summary page 1…SFE-200 Sun Medical Smoke Evacuator Circuit Reviewed and released under 51 0(k) 91154/A AUASQ OE2 Ko-05 j… |
What descends from it? (78)
See all 784 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083211 | Airseal Optical Trocar & Cannula System | 2008 | 51 |
| K071571 | Surgiquest Airseal Optical Trocar & Cannula System | 2007 | 36 |
| K062779 | Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector… | 2006 | 23 |
| K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal System | 2021 | 0 |
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 | — |
What is it indicated for?
To remove airborne particles generated by tissue combustion during laparoscopic surgery, via filtration of gaseous media contained within the distended pneumoperitoneum in order to significantly improve visualization.
LapEvac may be used in any laparoscopic surgery, as appropriate.
Sterile, single use only device
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052797 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052797: Lapevac, Filtration Device for the Periotoneum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052797
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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