Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The R Group — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K905415 | BRAIDED HIGH PRESSURE CATHETER CONNECTOR | The R Group | 1991-08-12 | 251 | 0 |
| K912076 | POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONF | The R Group | 1991-07-30 | 81 | 0 |
| K911549 | INJECTOR FILL TUBE | The R Group | 1991-07-18 | 101 | 0 |
| K905416 | VESSEL DILATOR | The R Group | 1991-03-25 | 111 | 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