Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
C.L. Mcintosh & Assoc., 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) |
|---|---|---|---|---|---|
| K972016 | AUTIMO 2.5-D AND AUTIMO 3-D | C.L. Mcintosh & Assoc., Inc. | 1997-12-04 | 188 | 0 |
| K970131 | ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE | C.L. Mcintosh & Assoc., Inc. | 1997-06-16 | 153 | 0 |
| K961725 | OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION | C.L. Mcintosh & Assoc., Inc. | 1996-08-01 | 90 | 0 |
| K942227 | NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM | C.L. Mcintosh & Assoc., Inc. | 1996-06-28 | 784 | 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