R-Group Intl.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “R-Group Intl.” (first 1992, latest 2000), across 5 product codes in 5 review panels. Median 510(k) review time under this name: 199 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 3 | 3 |
| CBT | Arterial Blood Sampling Kit | 1 | 1 |
| DRC | Trocar | 1 | 1 |
| GCD | Connector, Catheter | 1 | 1 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 1 | 1 |
Review panels
- General Hospital (3)
- Anesthesiology (1)
- Cardiovascular (1)
- Obstetrics and Gynecology (1)
- General and Plastic Surgery (1)
Most recent R-Group Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001233 | ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S | FPA | 2000-12-13 | 240 |
| K001599 | ACTI-FLEX IV ADMINISTRATION SET | FPA | 2000-09-18 | 117 |
| K993777 | DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES | HGI | 2000-05-25 | 199 |
| K952470 | ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. | GCD | 1995-11-28 | 186 |
| K954035 | ACTI-FLEX ARTERIAL EXTENSION SET | CBT | 1995-09-25 | 28 |
| K940319 | R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE | FPA | 1994-11-10 | 290 |
| K913267 | R-GROUP INTL. ONE WALL PUNCTURE NEEDLE | DRC | 1992-06-05 | 318 |
Recalls
openFDA lists no recalls under a recalling firm named R-Group Intl..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under R-Group Intl.?
FDA lists 7 510(k) clearances under the applicant name “R-Group Intl.” (first 1992, latest 2000), across 5 product codes in 5 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 R-Group Intl.?
The median time from FDA receipt to decision across 510(k)s cleared under the name R-Group Intl. is 199 days.
Which FDA product codes appear under R-Group Intl.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 3); CBT (Arterial Blood Sampling Kit, 1); DRC (Trocar, 1).
Next steps
- See all 7 R-Group Intl. clearances with predicates and recalls
- Run predicate analysis for product code FPA, R-Group Intl.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.