Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
R-Group Intl. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
199 daysmedian FDA review time
318 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001233 | ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S | R-Group Intl. | 2000-12-13 | 240 | 0 |
| K001599 | ACTI-FLEX IV ADMINISTRATION SET | R-Group Intl. | 2000-09-18 | 117 | 1 |
| K993777 | DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES | R-Group Intl. | 2000-05-25 | 199 | 0 |
| K952470 | ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. | R-Group Intl. | 1995-11-28 | 186 | 0 |
| K954035 | ACTI-FLEX ARTERIAL EXTENSION SET | R-Group Intl. | 1995-09-25 | 28 | 0 |
| K940319 | R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE | R-Group Intl. | 1994-11-10 | 290 | 0 |
| K913267 | R-GROUP INTL. ONE WALL PUNCTURE NEEDLE | R-Group Intl. | 1992-06-05 | 318 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda