# K980915: Valleylab Optimumm Smoke Evacuator System

- Pathway: 510(k) (Traditional)
- Applicant: Valleylab, Inc.
- Decided: Jun 29, 1998 after 110 days
- Product code: FYD (Apparatus, Exhaust, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.5070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K874512 (1988). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 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 3.
- K912651: Airsafe Minivac Smoke Filtration System, Stackhouse Assoc. (1991) Summary page 3.

## 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
- K142335: RapidVac Smoke Evacuator System (2015), 0 descendants of its own

## Indications for use
The Indications for Use of the Valleylab OptiMumm™ Smoke Evacuator system are for the removal of smoke and incidental fluids produced during electrosurgery and/or laser surgery. The removal of smoke from the surgical site improves visibility and reduces potential health hazards associated with surgical smoke.

Source page: https://510kreport.com/device/K980915
Methodology: https://510kreport.com/methodology