Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mar Cor Purification, 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) |
|---|---|---|---|---|---|
| K200670 | EON Portable RO Water Purification System | Mar Cor Purification, Inc. | 2020-04-16 | 34 | 0 |
| K192398 | Millenium HX | Mar Cor Purification, Inc. | 2019-10-03 | 30 | 0 |
| K133149 | BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM | Mar Cor Purification, Inc. | 2014-04-30 | 195 | 0 |
| K110578 | MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYS | Mar Cor Purification, Inc. | 2011-05-20 | 80 | 1 |
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