# K990037: Neptune Waste Management System

- Pathway: 510(k) (Traditional)
- Applicant: American Immuno Tech
- Decided: Aug 24, 1999 after 230 days
- Product code: FYD (Apparatus, Exhaust, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.5070
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K874512 (1988). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874512: Modified Biovac:Lfa Laser Fume Evacuation System, Stackhouse Assoc. (1988) Summary page 2.
- (no number) Steris® SafeCycle 40: named in the summary without a submission number
- (no number) Niche Medical SmartVac™: named in the summary without a submission number
- (no number) Dornoch Red>Away: named in the summary without a submission number

## 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
- 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
- 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, Pathology, Surgical Centers and Doctor's Offices to collect and sterilize surgical fluid waste as well as collect smoke generated from electro-cautery or laser devices.

Source page: https://510kreport.com/device/K990037
Methodology: https://510kreport.com/methodology