# K122278: Baylis Medical Company Radiofrequency Perforation Generator

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Company, Inc.
- Decided: Nov 7, 2012 after 100 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
Longest line of descent: 1 generation back to K013904 (2002). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013904: BMC Radio Frequency Perforation Generator, Models RFP-100-115 and RFP-100-230, Baylis Medical Co., Inc. (2002) Summary page 1.

## Most influential descendants
- K232809: Cross Vascular RF Generator and Footswitch (optional accessory) (2023), 1 descendant of its own
- K251566: TS-RF Generator (STS10) (2025), 0 descendants of its own
- K250275: PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch (2025), 0 descendants of its own
- K252083: HOTWIRE™ System RF Generator and Footswitch (optional accessory) (2025), 0 descendants of its own

## Indications for use
The Baylis Medical Company Radiofrequency Perforation Generator is indicated for use in general surgical procedures to cut and coagulate soft tissue.

Source page: https://510kreport.com/device/K122278
Methodology: https://510kreport.com/methodology