# K013904: BMC Radio Frequency Perforation Generator, Models RFP-100-115 and RFP-100-230

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Co., Inc.
- Decided: Feb 12, 2002 after 78 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.
5 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K122278: Baylis Medical Company Radiofrequency Perforation Generator (2012), 4 descendants of its own
- 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 BMC Radio Frequency Perforation Generator; Model RFP-100-115 (For Domestic Use) and Model RFP-100-230 (For International Use) is indicated for use in general surgical procedures to cu and coagulate soft tissue.

Source page: https://510kreport.com/device/K013904
Methodology: https://510kreport.com/methodology