# K012991: Neptune Waste Management Ststem

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Nov 29, 2001 after 84 days
- Product code: FYD (Apparatus, Exhaust, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.5070
- Recalls of this device: 6 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 4 cite it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K081047: Transposal Ultra Systems (2008), 4 descendants of its own
- K132671: Stryker Neptune 2 Waste Managment System (2013), 3 descendants of its own
- K153407: Stryker Neptune 3 Waste Management System (2016), 1 descendant of its own
- K080845: Orwell Fluid Collection and Disposal System (2008), 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

## Recalls of this device
- Jun 8, 2012 · Class I · Z-2063-2012: Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a p
- Jun 8, 2012 · Class I · Z-2062-2012: Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a p
- Jun 8, 2012 · Class I · Z-2061-2012: Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a p
- Jun 8, 2012 · Class I · Z-2064-2012: Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a p
- Oct 12, 2004 · Not classified · Z-0174-05: The grounding pin may break inside of the electrical plug, resulting in a shock hazard.
- Dec 3, 2002 · Not classified · Z-0524-03: Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R.

## Indications for use
The Neptune Waste management system is intended to be used in the Operating Room, Surgical Centers and Doctor's Offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electrocautory or laser devices.

Source page: https://510kreport.com/device/K012991
Methodology: https://510kreport.com/methodology