510(k) · Cleared
ClearedNEBULAE SRS Laparoscopic Surgical Smoke Removal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Northgate Technologies, Inc. · FYD Apparatus, Exhaust, Surgical
Cleared on Mar 25, 2021 as substantially equivalent to K052797 (Medtek Devices, Inc., 2006) after a 176-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Mar 25, 2021
- Review
- 176 days
- Class
- Class II
- Product code
- FYD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052797 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK052797 Lapevac, Filtration Device for the PeriotoneumMedtek Devices, Inc. · 2006
- This deviceK202944 NEBULAE SRS Laparoscopic Surgical Smoke Removal SystemNorthgate Technologies, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052797 | Lapevac, Filtration Device for the Periotoneum | Medtek Devices, Inc. | 2006 | — |
| 0 (this device) | K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal System | Northgate Technologies, Inc. | 2021 | — |
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 |
|---|---|---|---|
| * | K052797 | Lapevac, Filtration Device for the PeriotoneumSummary page 4…II Product Code(s): FYD Predicate Devices: MEDTEK DEVICES, INC. LAPEVAC, Filtration device for the Peritoneum (K052797) MEDTEK DEVICES Device Description: This 510(k) submission for the NEBULAE® SRS… | 2006 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K052797.
How does its category compare?
All FYD devicesFYD Apparatus, Exhaust, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
To remove airborne particles generated by tissue combustion during laparoscopic surgery, via filtration of gaseous media contained within the distended pneumoperitoneum in order to improve visualization. NEBULAE® SRS may be used in any laparoscopic surgery, as appropriate.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202944 · printed Nov 4, 2026
Cite this page
510(k) Report. “K202944: NEBULAE SRS Laparoscopic Surgical Smoke Removal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K202944
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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