Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Marpac, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041485 | MARPAC MESSENGER MODEL #501 | Marpac, Inc. | 2004-08-02 | 59 | 0 |
| K940567 | MODEL#1550 MARSONA(R) TINNITUS MASKER | Marpac, Inc. | 1994-07-06 | 148 | 0 |
| K802234 | BEDSIDE TINNITUS MASKER #1500 | Marpac, Inc. | 1980-10-10 | 25 | 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