Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cranial Technologies, 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) |
|---|---|---|---|---|---|
| K244056 | DOC Band 3D | Cranial Technologies, Inc. | 2025-03-17 | 76 | 0 |
| K042385 | DOC BAND-POSTOP | Cranial Technologies, Inc. | 2004-12-17 | 107 | 0 |
| K014012 | DOC BAND | Cranial Technologies, Inc. | 2002-01-28 | 54 | 0 |
| DEN980001 | DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND | Cranial Technologies, Inc. | 1998-05-29 | 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