Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Precision Therapy Intl., Inc. — 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) |
|---|---|---|---|---|---|
| K022411 | PRECISEPLAN 2.0 | Precision Therapy Intl., Inc. | 2002-09-20 | 58 | 4 |
| K002240 | RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0 | Precision Therapy Intl., Inc. | 2000-08-23 | 30 | 0 |
| K992864 | RENDER-PLAN 3-D | Precision Therapy Intl., Inc. | 1999-09-09 | 15 | 0 |
| K950061 | HERCULES RADIATION THERAPY COUCH | Precision Therapy Intl., Inc. | 1995-08-16 | 222 | 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