# K161358: Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instrument Service and Savings, Inc.
- Decided: Aug 3, 2017 after 444 days
- Product code: JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- 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.
No later device cites it as a predicate yet.
1 of 9 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K161358
Methodology: https://510kreport.com/methodology