Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IQE · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K821682 | TRUNCAL ORTHOSIS | Surgical Appliance Industries, Inc. | 1982-06-24 | 16 | 0 |
| K820051 | OBUS FORME ORTHOPEDIC BRACE, UPRIGHT | Obus Forme, Ltd. | 1982-01-29 | 21 | 0 |
| K812719 | PROSANA BELT | Bandwagon, Inc. | 1981-10-06 | 11 | 0 |
| K810450 | TRUNCAL ORTHOSIS | Fred Sammons, Inc. | 1981-03-04 | 13 | 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