Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intertherapy, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
110 daysmedian FDA review time
201 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K913763 | INTERPRET(TM) CATHETER LINEAR TRANSLATOR | Intertherapy, Inc. | 1991-11-20 | 90 | 0 |
| K912600 | INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER | Intertherapy, Inc. | 1991-11-19 | 162 | 0 |
| K910281 | INTRAVASCULAR IMAGING SYSTEM/MODIFIED | Intertherapy, Inc. | 1991-05-13 | 110 | 0 |
| K900305 | INTRAVASCULAR IMAGING SYSTEMS | Intertherapy, Inc. | 1990-04-20 | 89 | 0 |
| K895159 | INTRAVASCULAR IMAGING SYSTEM | Intertherapy, Inc. | 1990-03-12 | 201 | 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