510(k) · Cleared
ClearedValleylab Optimumm Smoke Evacuator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valleylab, Inc. · FYD Apparatus, Exhaust, Surgical
Cleared on Jun 29, 1998 as substantially equivalent to K874512 (Stackhouse Assoc., 1988) and 1 other predicate after a 110-day review. Its family tree reaches back 1 generation to 1988. 5 later devices descend from it.
- Decided
- Jun 29, 1998
- Review
- 110 days
- Class
- Class II
- Product code
- FYD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K874512 (1988). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK874512 Modified Biovac:Lfa Laser Fume Evacuation SystemStackhouse Assoc. · 1988
- This deviceK980915 Valleylab Optimumm Smoke Evacuator SystemValleylab, Inc. · 1998
- Descendant · cites it directly · 3 of its ownK132671 Stryker Neptune 2 Waste Managment SystemStryker Corporation · 2013 · Recalled
- Descendant · 2 generations on · 1 of its ownK153407 Stryker Neptune 3 Waste Management SystemStryker Corporation · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK222552 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold…Stryker Instruments · 2022
- Descendant · 2 generations on · 0 of its ownK161358 Medline ReNewal Reprocessed Stryker Neptune 2 ManifoldsSurgical Instrument Service and Savings, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK142335 RapidVac Smoke Evacuator SystemCovidien · 2015
Most influential descendants
Showing 5 of 5 · See all- K132671Stryker Neptune 2 Waste Managment SystemStryker Corporation · 2013 · cites it directly3descendants
- K153407Stryker Neptune 3 Waste Management SystemStryker Corporation · 2016 · 2 generations on1descendant
- K222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen…Stryker Instruments · 2022 · 2 generations on0descendants
- K161358Medline ReNewal Reprocessed Stryker Neptune 2 ManifoldsSurgical Instrument Service and Savings, Inc. · 2017 · 2 generations on0descendants
- K142335RapidVac Smoke Evacuator SystemCovidien · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874512 | Modified Biovac:Lfa Laser Fume Evacuation System | Stackhouse Assoc. | 1988 | — |
| 0 (this device) | K980915 | Valleylab Optimumm Smoke Evacuator System | Valleylab, Inc. | 1998 | — |
| +1 | K132671 | Stryker Neptune 2 Waste Managment System | Stryker Corporation | 2013 | 5 |
| +2 | K153407 | Stryker Neptune 3 Waste Management System | Stryker Corporation | 2016 | 1 |
| +2 | K222552 | 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2… | Stryker Instruments | 2022 | — |
| +2 | K161358 | Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds | Surgical Instrument Service and Savings, Inc. | 2017 | — |
| +1 | K142335 | RapidVac Smoke Evacuator System | Covidien | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K874512 | Modified Biovac:Lfa Laser Fume Evacuation SystemSummary page 3…r Their intended purpose is to remove electrosurgical/laser smoke from the surgical site. The Point One smoke evacuator received FDA concurrence under accession number K874512 on 1/27/88 and the MiniVac received FDA concurrence under accession # K912651 on 7/8/91. Both of the above Stackhouse smoke evac… | 1988 |
| * | K912651 | Airsafe Minivac Smoke Filtration SystemSummary page 3…rgical site. The Point One smoke evacuator received FDA concurrence under accession number K874512 on 1/27/88 and the MiniVac received FDA concurrence under accession # K912651 on 7/8/91. Both of the above Stackhouse smoke evacuators and the Valleylab OptiMumm™ smoke evacuator are similar in dimensional… | 1991 |
What descends from it? (5)
2 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?
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?
The Indications for Use of the Valleylab OptiMumm™ Smoke Evacuator system are for the removal of smoke and incidental fluids produced during electrosurgery and/or laser surgery. The removal of smoke from the surgical site improves visibility and reduces potential health hazards associated with surgical smoke.
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/K980915 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980915: Valleylab Optimumm Smoke Evacuator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980915
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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