Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Foundations Plus, 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) |
|---|---|---|---|---|---|
| K871138 | FOUNDATIONS PLUS ABDOMINAL BAND 1100 | Foundations Plus, Inc. | 1987-04-23 | 31 | 0 |
| K864477 | FOUNDATIONS PLUS GIRDLE SUPPORT GARMENT 5000 | Foundations Plus, Inc. | 1986-12-02 | 19 | 0 |
| K863753 | FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000 | Foundations Plus, Inc. | 1986-10-30 | 35 | 0 |
| K863754 | FOUNDATIONS PLUS FACIAL-CHIN-NECK SUPPORTER 1000 | Foundations Plus, Inc. | 1986-10-17 | 22 | 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