# K153407: Stryker Neptune 3 Waste Management System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Apr 25, 2016 after 152 days
- Product code: JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K874512 (1988). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132671: Stryker Neptune 2 Waste Managment System, Stryker Corporation (2013) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Jul 1, 2016 · Class II · Z-2630-2016: Stryker initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potential for the device to experience system errors causing the device to shutdown if high levels of electrom

## Indications for use
The Neptune 3 Waste Management System is intended to be used in the operating room, pathology, surgical centers and doctor's offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electrocautery or laser devices.

Source page: https://510kreport.com/device/K153407
Methodology: https://510kreport.com/methodology