# K200250: Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Megadyne Medical Products, Inc.
- Decided: Jun 26, 2020 after 144 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: 2 generations back to K932230 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163659: Crystal Vision, I.C Medical, Inc. (2017) Summary page 4.

## Indications for use
The Megadyne Smoke Evacuator with accessories is intended to remove smoke created in surgical procedures at the surgical site.

Source page: https://510kreport.com/device/K200250
Methodology: https://510kreport.com/methodology