510(k) · Cleared
Recalled · Class I · 2012Neptune Waste Management Ststem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · FYD Apparatus, Exhaust, Surgical
Cleared on Nov 29, 2001 after an 84-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 8 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it. It has been recalled 6 times, including 4 Class I recalls.
- Decided
- Nov 29, 2001
- Review
- 84 days
- Class
- Class II
- Product code
- FYD
- Recalls
- 6 (4 Class I)
- Predicates
- 0
7 later devices descend from it, 4 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- This deviceK012991 Neptune Waste Management StstemStryker Instruments · 2001
- Descendant · cites it directly · 4 of its ownK081047 Transposal Ultra SystemsDornoch Medical Systems, Inc. · 2008
- 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 · cites it directly · 1 of its ownK080845 Orwell Fluid Collection and Disposal SystemCardinalhealth · 2008
- Descendant · 2 generations on · 0 of its ownK222552 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold…Stryker Instruments · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K081047Transposal Ultra SystemsDornoch Medical Systems, Inc. · 2008 · cites it directly4descendants
- K132671Stryker Neptune 2 Waste Managment SystemStryker Corporation · 2013 · cites it directly3descendants
- K153407Stryker Neptune 3 Waste Management SystemStryker Corporation · 2016 · 2 generations on1descendant
- K080845Orwell Fluid Collection and Disposal SystemCardinalhealth · 2008 · cites it directly1descendant
- K222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen…Stryker Instruments · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012991 | Neptune Waste Management Ststem | Stryker Instruments | 2001 | — |
| +1 | K081047 | Transposal Ultra Systems | Dornoch Medical Systems, Inc. | 2008 | — |
| +1 | K132671 | Stryker Neptune 2 Waste Managment System | Stryker Corporation | 2013 | 5 |
| +2 | K153407 | Stryker Neptune 3 Waste Management System | Stryker Corporation | 2016 | 1 |
| +1 | K080845 | Orwell Fluid Collection and Disposal System | Cardinalhealth | 2008 | — |
| +2 | K222552 | 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2… | Stryker Instruments | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 8, 2012 | Class I | Z-2063-2012 | Labeling False and Misleading | Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post… |
| Jun 8, 2012 | Class I | Z-2062-2012 | Labeling False and Misleading | Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post… |
| Jun 8, 2012 | Class I | Z-2061-2012 | Labeling False and Misleading | Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post… |
| Jun 8, 2012 | Class I | Z-2064-2012 | Labeling False and Misleading | Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post… |
| 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. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K081047 (Dornoch Medical Systems, Inc., 2008) has gone furthest, with 4 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?
The Neptune Waste management system is intended to be used in the Operating Room, Surgical Centers and Doctor's Offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electrocautory or laser devices.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K012991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012991: Neptune Waste Management Ststem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012991
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026