# K081047: Transposal Ultra Systems

- Pathway: 510(k) (Traditional)
- Applicant: Dornoch Medical Systems, Inc.
- Decided: Apr 29, 2008 after 15 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: 2 generations back to K874512 (1988). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941527: Model 2300 General Purpose Suction Pump, Product & Educational Services (1994) Summary page 1.
- K990037: Neptune Waste Management System, American Immuno Tech (1999) Summary page 1.
- K012991: Neptune Waste Management Ststem, Stryker Instruments (2001) Summary page 1.
- (no number) Steris - SafeCycle 40: named in the summary without a submission number

## Most influential descendants
- 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

## Indications for use
The Dornoch Transposal Ultra System is self-powered suction / vacuum pump intended to collect and dispose of liquid waste within Hospital Operating Rooms, Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices.

Source page: https://510kreport.com/device/K081047
Methodology: https://510kreport.com/methodology