# K021329: Rita System

- Pathway: 510(k) (Traditional)
- Applicant: Rita Medical Systems
- Decided: Oct 9, 2002 after 166 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: 3 generations back to K870028 (1987). 9 ancestors in all.
76 later devices descend from it; 2 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983214: Rita RF Generator and Accessories, Model 500 Series, Rita Medical Systems (2000) Summary page 1.
- K992693: Rita Model 90 Electrosurgical Accessory, Model 90, Rita Medical Systems (1999) Summary page 1.
- K993944: Rita Model 1500 Electrosurgical Generator, Power Cord,Footswitch,Main Cable, Dispersive Electrode, Rita Medical Systems (1999) Summary page 1.
- K003676: Rita Model 2500 Electrosurgical RF Generator, Rita Medical Systems (2001) Summary page 1.
- K963577: Radionics Sluijter-Mehta Cannula, Radionics, Inc. (1996) Summary page 1.
- K965182: RFG-3CF, Radionics, Inc. (1997) Summary page 1.
- K980430: Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS), Radionics, Inc. (1998) Summary page 1.
- K982489: RFG-3C Plus, Radionics, Inc. (1998) Summary page 1.

## Most influential descendants
- K042216: Cool-Tip RF Ablation System (2004), 75 descendants of its own
- K052796: Cool-Tip RF Generator, Cool-Tip RF System Accessories (2006), 56 descendants of its own
- K053290: Cool-Tip RF Generator, Cool-Tip RF System Accessories (2006), 50 descendants of its own
- K072687: Valleylab Microwave Ablation Generator (2008), 42 descendants of its own
- K100744: Certus 140 Microwave Ablation System and Accessories, Model Certus 140 (2010), 39 descendants of its own

## Indications for use
The RITA® System (RF generator and electrosurgical devices) supplies energy for use in electrosurgery and is indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue, including: the partial or complete ablation of non-resectable liver lesions and the palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard pain therapy.

Source page: https://510kreport.com/device/K021329
Methodology: https://510kreport.com/methodology