# K020510: Smoke Evacuation Hoses/Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Dm Medical, Inc.
- Decided: May 3, 2002 after 77 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 K922555 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922555: Enviromate (TM) Smoke Evacuation System, Lase, Inc. (1993) Summary page 2.

## Indications for use
The smoke evacuation hoses are intended for the removal of smoke and particles generated from the point of surgical activity during a medical procedure that uses an electrosurgical pencil or laser for cutting and/or cauterizing. The are to be connected to a smoke evacuation unit securely on one end and the other end is to be held at the surgical site no farther than 2” from the point of lasering or cauterizing of tissue. They are a single use item, considered a bio-hazardous item after use in surgery, and must be disposed of after each case in a bio-hazardous bag (a red bag).

Source page: https://510kreport.com/device/K020510
Methodology: https://510kreport.com/methodology