Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Martin'S Maine Exchange · 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) |
|---|---|---|---|---|---|
| K810008 | ALP-KII | Martin'S Maine Exchange | 1981-01-16 | 11 | 0 |
| K801837 | PLASTIC STRIP BANDAGES | Martin'S Maine Exchange | 1980-10-31 | 91 | 0 |
| K801839 | DISPOSABLE HYPODERMIC NEEDLES | Martin'S Maine Exchange | 1980-09-16 | 46 | 0 |
| K801840 | SURGICAL BANDAGES/SUNLEEP DX | Martin'S Maine Exchange | 1980-09-09 | 39 | 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