510(k) · Cleared
Cleared120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Cleared on Dec 9, 2022 as substantially equivalent to K153407 (Stryker Corporation, 2016) and 1 other predicate after a 108-day review. Its family tree reaches back 5 generations to 1988. 1 of the 10 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 9, 2022
- Review
- 108 days
- Class
- Class II
- Product code
- JCX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K874512 (1988). 9 ancestors in all. No later device cites it as a predicate yet. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK874512 Modified Biovac:Lfa Laser Fume Evacuation SystemStackhouse Assoc. · 1988
- 4 generations backK990037 Neptune Waste Management SystemAmerican Immuno Tech · 1999 · Recalled
- 3 generations backK081047 Transposal Ultra SystemsDornoch Medical Systems, Inc. · 2008
- 2 generations backK132671 Stryker Neptune 2 Waste Managment SystemStryker Corporation · 2013 · Recalled
- 1 generation backK153407 Stryker Neptune 3 Waste Management SystemStryker Corporation · 2016 · Recalled
- This deviceK222552 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold…Stryker Instruments · 2022
Class I recalls in this family
- K012991 Neptune Waste Management Ststem2 generations back · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K874512 | Modified Biovac:Lfa Laser Fume Evacuation System | Stackhouse Assoc. | 1988 | — |
| −4 | K990037 | Neptune Waste Management System | American Immuno Tech | 1999 | 2 |
| −3 | K081047 | Transposal Ultra Systems | Dornoch Medical Systems, Inc. | 2008 | — |
| −2 | K132671 | Stryker Neptune 2 Waste Managment System | Stryker Corporation | 2013 | 5 |
| −1 | K153407 | Stryker Neptune 3 Waste Management System | Stryker Corporation | 2016 | 1 |
| 0 (this device) | K222552 | 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2… | Stryker Instruments | 2022 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K153407 | Stryker Neptune 3 Waste Management SystemSummary page 4…510(k) Product Manufacturer Code Neptune 3 Waste Management K153407 JCX Stryker Instruments System 1941 Stry… | 2016 |
| * | K132671 | Stryker Neptune 2 Waste Managment SystemSummary page 4…1941 Stryker Way Portage, MI 49002 Neptune 2 Manifolds K132671 JCX Stryker Instruments 1941 Stry… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 2 generations back · ◆ in the 2001 ancestors bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 6.6 years on median.
- 4 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
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. 2022, 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 S Waste Management System is indicated for use in procedures where collecting and disposing of fluid waste and capturing suctioned tissue specimens is desired. It is intended to be used in operating rooms, pathology, surgical centers, procedure rooms, and for endoscopic procedures, such as colonoscopies, esophagogastroduodenoscopies (EGDs), and bronchoscopies.
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/K222552 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222552: 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222552
Report an extraction error
Are you the manufacturer?
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