510(k) · Cleared
Recalled · Class II · 2026Stryker Neptune 2 Waste Managment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Cleared on Dec 20, 2013 as substantially equivalent to K012991 (Stryker Instruments, 2001) and 2 other predicates after a 115-day review. Its family tree reaches back 3 generations to 1988. 1 of the 11 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled 5 times.
- Decided
- Dec 20, 2013
- Review
- 115 days
- Class
- Class II
- Product code
- JCX
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 3 generations to K874512 (1988). 7 ancestors in all. 3 later devices descend from it, 3 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK874512 Modified Biovac:Lfa Laser Fume Evacuation SystemStackhouse Assoc. · 1988
- 2 generations backK990037 Neptune Waste Management SystemAmerican Immuno Tech · 1999 · Recalled
- 1 generation backK081047 Transposal Ultra SystemsDornoch Medical Systems, Inc. · 2008
- This deviceK132671 Stryker Neptune 2 Waste Managment SystemStryker Corporation · 2013
- Descendant · cites it directly · 1 of its ownK153407 Stryker Neptune 3 Waste Management SystemStryker Corporation · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK222552 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold…Stryker Instruments · 2022
- Descendant · cites it directly · 0 of its ownK161358 Medline ReNewal Reprocessed Stryker Neptune 2 ManifoldsSurgical Instrument Service and Savings, Inc. · 2017
Class I recalls in this family
- K012991 Neptune Waste Management Ststemdirect predicate · 2001
Most influential descendants
Showing 3 of 3 · See all- K153407Stryker Neptune 3 Waste Management SystemStryker Corporation · 2016 · cites it directly1descendant
- K222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen…Stryker Instruments · 2022 · cites it directly0descendants
- K161358Medline ReNewal Reprocessed Stryker Neptune 2 ManifoldsSurgical Instrument Service and Savings, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K874512 | Modified Biovac:Lfa Laser Fume Evacuation System | Stackhouse Assoc. | 1988 | — |
| −2 | K990037 | Neptune Waste Management System | American Immuno Tech | 1999 | 2 |
| −1 | K081047 | Transposal Ultra Systems | Dornoch Medical Systems, Inc. | 2008 | — |
| 0 (this device) | K132671 | Stryker Neptune 2 Waste Managment System | Stryker Corporation | 2013 | — |
| +1 | K153407 | Stryker Neptune 3 Waste Management System | Stryker Corporation | 2016 | 1 |
| +1 | K222552 | 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2… | Stryker Instruments | 2022 | — |
| +1 | K161358 | Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds | Surgical Instrument Service and Savings, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 JCX device
- #1 K250964 Protable Phlegm Suction Unit (JMA D01)score 12.2 · 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? (3)
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 |
|---|---|---|---|
| * | K012991 | Neptune Waste Management StstemSummary page 1…FYD apparatus, exhaust, surgical 21 CFR 878.5070 Predicate Stryker@ Neptune Waste Management System (K012991) Devices: Dornoch Transposal Ultra System (K081047). Valleylab OptiMumm Smoke… | 2001 |
| * | K081047 | Transposal Ultra SystemsSummary page 1…21 CFR 878.5070 Predicate Stryker@ Neptune Waste Management System (K012991) Devices: Dornoch Transposal Ultra System (K081047). Valleylab OptiMumm Smoke Evacuator System (K98091 5)… | 2008 |
| * | K980915 | Valleylab Optimumm Smoke Evacuator SystemSummary page 1…gement System (K012991) Devices: Dornoch Transposal Ultra System (K081047). Valleylab OptiMumm Smoke Evacuator System (K98091 5) Section 005 - I Device The Neptune 2 Waste Ma… | 1998 |
What descends from it? (3)
3 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 |
|---|---|---|---|---|
| May 6, 2026 | Class II | Z-2282-2026 | Nonconforming Material/Component | It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a potential risk of… |
| Jul 20, 2015 | Class II | Z-2524-2015 | Nonconforming Material/Component | The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be out of specification. This can cut or dislodge the PTFE seal and cause a leak between the Rover and Docker couplers during docking or leaking… |
| May 22, 2015 | Class II | Z-2099-2015 | Nonconforming Material/Component | Stryker Instruments is initiating a recall of the Neptune 2 Waste Management System due to complaints related to installation failures of the Neptune 2 diverter valve assembly during docking. |
| Dec 30, 2013 | Class II | Z-0902-2014 | Device Design | The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the recently obtained 510(k) clearance specifications. |
| Dec 30, 2013 | Class II | Z-0903-2014 | Device Design | The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the recently obtained 510(k) clearance specifications. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K012991Neptune Waste Management StstemStryker Instruments · 2001 · Direct predicate · ◆ in the 2001 ancestors bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 8.7 years on median.
- 2 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K153407 (Stryker Corporation, 2016) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K012991.
How does its category compare?
All JCX devicesJCX Apparatus, Suction, Ward Use, Portable, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JCX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JCX
30in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JCX
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JCX
45in 2025
MAUDE reports naming product code JCX, 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 | 48 |
| 2008 | 4 | 43 | 3 | 57 |
| 2009 | 1 | — | 0 | 34 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 2 | — | 2 | 9 |
| 2012 | 2 | — | 0 | 18 |
| 2013 | 5 | 144 | 2 | 12 |
| 2014 | 4 | 106 | 0 | 68 |
| 2015 | 0 | — | 0 | 118 |
| 2016 | 2 | — | 0 | 119 |
| 2017 | 2 | — | 1 | 102 |
| 2018 | 2 | — | 0 | 170 |
| 2019 | 3 | 30 | 0 | 132 |
| 2020 | 0 | — | 1 | 89 |
| 2021 | 0 | — | 0 | 227 |
| 2022 | 1 | — | 0 | 215 |
| 2023 | 1 | — | 0 | 187 |
| 2024 | 1 | — | 0 | 103 |
| 2025 | 2 | — | 0 | 45 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Neptune 2 Waste Management System Is intended to be used in the operating room,
pathology, surgical centers, and doctors offices to collect and dispase of surgical fluid waste
as well as collect smoke generated from electrocautery 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/K132671 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132671: Stryker Neptune 2 Waste Managment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132671
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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