Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Circulator Boot 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) |
|---|---|---|---|---|---|
| K082134 | CIRCULATOR BOOT | Circulator Boot Corp. | 2009-05-07 | 282 | 0 |
| K971026 | THE CIRCULATOR BOOT | Circulator Boot Corp. | 1997-08-14 | 147 | 0 |
| K833627 | CIRCULATOR MINIBOOT | Circulator Boot Corp. | 1984-05-23 | 222 | 0 |
| K792354 | THE CIRCULATOR BOOT | Circulator Boot Corp. | 1980-01-09 | 50 | 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