510(k) · Cleared
ClearedMedline ReNewal Reprocessed Stryker Neptune 2 Manifolds
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Instrument Service and Savings, Inc. · JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Cleared on Aug 3, 2017 as substantially equivalent to K132671 (Stryker Corporation, 2013) after a 444-day review. Its family tree reaches back 4 generations to 1988. 1 of the 9 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 3, 2017
- Review
- 444 days
- Class
- Class II
- Product code
- JCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K874512 (1988). 8 ancestors in all. No later device cites it as a predicate yet. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK874512 Modified Biovac:Lfa Laser Fume Evacuation SystemStackhouse Assoc. · 1988
- 3 generations backK990037 Neptune Waste Management SystemAmerican Immuno Tech · 1999 · Recalled
- 2 generations backK081047 Transposal Ultra SystemsDornoch Medical Systems, Inc. · 2008
- 1 generation backK132671 Stryker Neptune 2 Waste Managment SystemStryker Corporation · 2013 · Recalled
- This deviceK161358 Medline ReNewal Reprocessed Stryker Neptune 2 ManifoldsSurgical Instrument Service and Savings, Inc. · 2017
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 |
|---|---|---|---|---|---|
| −4 | K874512 | Modified Biovac:Lfa Laser Fume Evacuation System | Stackhouse Assoc. | 1988 | — |
| −3 | K990037 | Neptune Waste Management System | American Immuno Tech | 1999 | 2 |
| −2 | K081047 | Transposal Ultra Systems | Dornoch Medical Systems, Inc. | 2008 | — |
| −1 | K132671 | Stryker Neptune 2 Waste Managment System | Stryker Corporation | 2013 | 5 |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K132671 | Stryker Neptune 2 Waste Managment SystemSummary page 4…Device Models • 0702-020-000 Neptune 2 4-Port Manifold; and • 0702-020-001 Neptune 2 Specimen Collection 4-Port Manifold. Predicate K132671 – Stryker Neptune 2 Waste Management System Manifolds Device The Medline ReNewal Reprocessed Stryker Neptune 2 M… | 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 29 years and passes through 5 companies; a new generation was cleared every 8.7 years on median.
- 3 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K132671.
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. 2017, 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 Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds are accessories for use with the Stryker Neptune 2 Waste Management System, specifically the rover.
The Neptune 2 Waste Management system is intended to be used in the operating room, pathology laboratories, surgical centers and doctor’s offices to collect and dispose of surgical fluid waste and to collect smoke generated by electrocautery or laser devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161358 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161358: Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161358
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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