Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Radionics Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
162 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K844299 | CORNEOMAP 4500 | Radionics Medical, Inc. | 1985-04-18 | 162 | 0 |
| K833222 | SINUSVU 2500 | Radionics Medical, Inc. | 1983-11-28 | 101 | 0 |
| K837331 | CORNEOMAP 4500 ULTRASOUND MEASUREMENT | Radionics Medical, Inc. | 1983-05-09 | 60 | 0 |
| K827035 | OCULAR BIOMETER 4000 | Radionics Medical, Inc. | 1982-07-22 | 90 | 0 |
| K810851 | SPECTRUM ANALYZER 8000 | Radionics Medical, Inc. | 1981-04-23 | 24 | 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