Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Isopure, Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
156 daysmedian FDA review time
272 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191093 | Isopure Dry Acid Dissolution System | Isopure, Corp. | 2020-01-22 | 272 | 0 |
| K120005 | ACDS | Isopure, Corp. | 2012-03-29 | 86 | 2 |
| K112427 | BICARB MIXING AND DISTRIBUTION SYSTEM | Isopure, Corp. | 2012-01-26 | 156 | 1 |
| K041163 | ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND M | Isopure, Corp. | 2004-10-07 | 157 | 1 |
| K993200 | MD 420/440/460/470/480/490 | Isopure, Corp. | 2000-01-24 | 122 | 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