# K981888: Smoke-Evac

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Medical Devices, Inc.
- Decided: Oct 15, 1998 after 139 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have 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.

## Indications for use
A vacuum powered body fluid (smoke) suction apparatus that is used to remove body fluids. In this particular case the fluid is the smoke that is generated during electrosurgical procedures. The device is powered by an external source of vacuum. This device includes rigid suction tubes, tips, and connecting tubes.

Source page: https://510kreport.com/device/K981888
Methodology: https://510kreport.com/methodology