510(k) · Cleared
Recalled · 2004Neptune Waste Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Immuno Tech · FYD Apparatus, Exhaust, Surgical
Cleared on Aug 24, 1999 as substantially equivalent to K874512 (Stackhouse Assoc., 1988) after a 230-day review. Its family tree reaches back 1 generation to 1988. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 24, 1999
- Review
- 230 days
- Class
- Class II
- Product code
- FYD
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K874512 (1988). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK874512 Modified Biovac:Lfa Laser Fume Evacuation SystemStackhouse Assoc. · 1988
- This deviceK990037 Neptune Waste Management SystemAmerican Immuno Tech · 1999
- Descendant · cites it directly · 4 of its ownK081047 Transposal Ultra SystemsDornoch Medical Systems, Inc. · 2008
- Descendant · 2 generations on · 3 of its ownK132671 Stryker Neptune 2 Waste Managment SystemStryker Corporation · 2013 · Recalled
- Descendant · 3 generations on · 1 of its ownK153407 Stryker Neptune 3 Waste Management SystemStryker Corporation · 2016 · Recalled
- Descendant · 3 generations on · 0 of its ownK222552 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold…Stryker Instruments · 2022
- Descendant · 3 generations on · 0 of its ownK161358 Medline ReNewal Reprocessed Stryker Neptune 2 ManifoldsSurgical Instrument Service and Savings, Inc. · 2017
Most influential descendants
Showing 5 of 5 · See all- K081047Transposal Ultra SystemsDornoch Medical Systems, Inc. · 2008 · cites it directly4descendants
- K132671Stryker Neptune 2 Waste Managment SystemStryker Corporation · 2013 · 2 generations on3descendants
- K153407Stryker Neptune 3 Waste Management SystemStryker Corporation · 2016 · 3 generations on1descendant
- K222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen…Stryker Instruments · 2022 · 3 generations on0descendants
- K161358Medline ReNewal Reprocessed Stryker Neptune 2 ManifoldsSurgical Instrument Service and Savings, Inc. · 2017 · 3 generations on0descendants
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) | K990037 | Neptune Waste Management System | American Immuno Tech | 1999 | — |
| +1 | K081047 | Transposal Ultra Systems | Dornoch Medical Systems, Inc. | 2008 | — |
| +2 | K132671 | Stryker Neptune 2 Waste Managment System | Stryker Corporation | 2013 | 5 |
| +3 | K153407 | Stryker Neptune 3 Waste Management System | Stryker Corporation | 2016 | 1 |
| +3 | K222552 | 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2… | Stryker Instruments | 2022 | — |
| +3 | K161358 | Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds | Surgical Instrument Service and Savings, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 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? (4)
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 2…l SmartVac™, a smoke evacuation system; the Dornoch Red>Away, an infectious fluid collection and disposal system; and the Stackhouse Biovac Laser Fume Evacuation System (K874512). Performance testing: Testing was conducted on the Neptune Waste Management System to verify the ability of the Neptune Waste M… | 1988 |
| * | — | Steris® SafeCycle 40 Named without a submission number | |
| * | — | Niche Medical SmartVac™ Named without a submission number | |
| * | — | Dornoch Red>Away Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081047 | Transposal Ultra Systems | 2008 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 12, 2004 | Not classified | Z-0174-05 | Other | The grounding pin may break inside of the electrical plug, resulting in a shock hazard. |
| Dec 3, 2002 | Not classified | Z-0524-03 | Other | Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R. |
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 Neptune Waste Management System is intended to be used in the Operating Room, Pathology, Surgical Centers and Doctor's Offices to collect and sterilize surgical fluid waste as well as collect smoke generated from electro-cautery or laser devices.
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/K990037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990037: Neptune Waste Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990037
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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