Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Swims America Corp — 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) |
|---|---|---|---|---|---|
| K230167 | BACK 4 | Swims America Corp | 2023-09-14 | 237 | 0 |
| K230037 | BACK 3 | Swims America Corp | 2023-07-19 | 194 | 0 |
| K220014 | RSHOCK | Swims America Corp | 2023-03-01 | 420 | 0 |
| K214090 | Back 3 COLOR | Swims America Corp | 2022-11-01 | 308 | 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