Rita Medical Systems: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Rita Medical Systems” (first 1998, latest 2007), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 29 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 14 | 14 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 2 | 2 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 2 | 2 |
| GXD | Generator, Lesion, Radiofrequency | 1 | 1 |
| MRZ | Accessories, Pump, Infusion | 1 | 1 |
Review panels
- General and Plastic Surgery (14)
- General Hospital (5)
- Neurology (1)
Most recent Rita Medical Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070101 | UNIBLATE ELECTROSURGICAL DEVICE | GEI | 2007-02-14 | 35 |
| K062414 | VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET | LJT | 2007-02-01 | 168 |
| K062579 | OMNIPICC P.I. | LJS | 2006-11-28 | 89 |
| K062935 | HABIB 4X LAPAROSCOPIC | GEI | 2006-10-13 | 15 |
| K051102 | OMNIPICC PI | LJS | 2005-11-23 | 208 |
| K050176 | VORTEX EZ VASCULAR ACCESS PORT | LJT | 2005-02-25 | 30 |
| K040989 | RITA SYSTEMS | GEI | 2004-04-28 | 12 |
| K032149 | RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR | GEI | 2003-09-09 | 57 |
| K031926 | RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER) | GEI | 2003-07-17 | 24 |
| K031257 | RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR | GEI | 2003-05-02 | 11 |
10 earlier clearances. See the full list in Caduvo.
Recalls
9 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2007-10-03.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Rita Medical Systems (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MRZ)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MRZ)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via MRZ)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rita Medical Systems?
FDA lists 20 510(k) clearances under the applicant name “Rita Medical Systems” (first 1998, latest 2007), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Rita Medical Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rita Medical Systems is 29 days.
Which FDA product codes appear under Rita Medical Systems?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 14); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 2); LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 2).
Next steps
- See all 20 Rita Medical Systems clearances with predicates and recalls
- Run predicate analysis for product code GEI, Rita Medical Systems's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.