Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
IPX · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K823662 | RIB BELT (UNIVERSAL) | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823158 | RIB BELT (UNIVERSAL) | Warm & Form, Orthopedic Materials | 1982-11-10 | 16 | 0 |
| K803239 | SOFTGOOD PRODUCTS AND SPLINTS | Danek Medical, Inc. | 1981-01-09 | 17 | 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