Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Radius Intl., Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
235 daysmedian FDA review time
730 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972025 | RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT | Radius Intl., Inc. | 1998-01-23 | 235 | 29 |
| K972102 | RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GAST | Radius Intl., Inc. | 1998-01-23 | 233 | 0 |
| K971901 | RADIUS LOW PROFILE GASTROSTOMY TUBE KIT | Radius Intl., Inc. | 1998-01-22 | 244 | 0 |
| K951560 | RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND | Radius Intl., Inc. | 1995-04-17 | 12 | 0 |
| K930510 | RADIUS ENTERAL FEEDING TUBE | Radius Intl., Inc. | 1995-02-01 | 730 | 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