Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pollenex Associated Mills, 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) |
|---|---|---|---|---|---|
| K843010 | BP-800 | Pollenex Associated Mills, Inc. | 1985-05-29 | 301 | 0 |
| K843446 | DIGITAL SPHYGMOMANOMETER BP-2500 | Pollenex Associated Mills, Inc. | 1985-05-15 | 252 | 0 |
| K843009 | BP-1000 | Pollenex Associated Mills, Inc. | 1984-08-24 | 23 | 0 |
| K832913 | BACK MASSAGER B-400 ADJUSTABLE | Pollenex Associated Mills, Inc. | 1983-11-07 | 70 | 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