Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rastronics USA, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
114 daysmedian FDA review time
140 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K902244 | RASTRONICS CCI 8 | Rastronics USA, Inc. | 1990-10-05 | 140 | 0 |
| K902252 | RASTRONICS CCI 10/3 HEARING AID ANALYSIS | Rastronics USA, Inc. | 1990-09-12 | 114 | 0 |
| K902287 | RASTRONICS PORTAREM 20 | Rastronics USA, Inc. | 1990-08-09 | 79 | 0 |
| K890864 | HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS. | Rastronics USA, Inc. | 1989-06-21 | 120 | 0 |
| K853320 | FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10 | Rastronics USA, Inc. | 1985-09-27 | 59 | 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