# K972846: BMC RF Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Co., Inc.
- Decided: Jul 17, 1998 after 350 days
- Product code: GXI (Probe, Radiofrequency Lesion)
- Device class: 2
- Regulation: 21 CFR 882.4725
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 4 cite it directly.
0 of 10 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
- K102566: Owl Cannulae (2011), 3 descendants of its own
- K141586: Owl Cannulae (2014), 2 descendants of its own
- K121773: Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode (2012), 2 descendants of its own
- K092337: Pain Management Optima, Model PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS (2009), 1 descendant of its own
- K190259: Vesta RF Cannula (2020), 0 descendants of its own

## Recalls of this device
- Oct 29, 2013 · Class II · Z-0850-2014: Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.
- Oct 4, 2012 · Class II · Z-0879-2013: A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually packaged cannula had not been sealed along 

## Indications for use
The BMC RF Cannula 1s intended for use in radio-frequency (RF) Heat lesion procedures for relief of pain.

Source page: https://510kreport.com/device/K972846
Methodology: https://510kreport.com/methodology