Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bioform, 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) |
|---|---|---|---|---|---|
| K033398 | LARYNGEAL AUGMENTATION IMPLANT | Bioform, Inc. | 2003-12-12 | 49 | 0 |
| K030682 | CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038- | Bioform, Inc. | 2003-06-27 | 114 | 0 |
| K013243 | COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0 | Bioform, Inc. | 2002-01-09 | 103 | 1 |
| K012955 | COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER | Bioform, Inc. | 2001-10-22 | 48 | 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