# K132671: Stryker Neptune 2 Waste Managment System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Dec 20, 2013 after 115 days
- Product code: JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K874512 (1988). 7 ancestors in all.
3 later devices descend from it; 3 cite it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012991: Neptune Waste Management Ststem, Stryker Instruments (2001) Summary page 1.
- K081047: Transposal Ultra Systems, Dornoch Medical Systems, Inc. (2008) Summary page 1.
- K980915: Valleylab Optimumm Smoke Evacuator System, Valleylab, Inc. (1998) Summary page 1.

## Most influential descendants
- K153407: Stryker Neptune 3 Waste Management System (2016), 1 descendant of its own
- 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) (2022), 0 descendants of its own
- K161358: Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds (2017), 0 descendants of its own

## Recalls of this device
- May 6, 2026 · Class II · Z-2282-2026: 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
- Jul 20, 2015 · Class II · Z-2524-2015: 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 Doc
- May 22, 2015 · Class II · Z-2099-2015: 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: 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: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K132671
Methodology: https://510kreport.com/methodology