Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Di-Chem, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
179 daysmedian FDA review time
711 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202508 | Hemo-Lyte C Cartridge | Di-Chem, Inc. | 2022-08-12 | 711 | 0 |
| K171015 | Citryte | Di-Chem, Inc. | 2017-10-13 | 192 | 0 |
| K012328 | HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER | Di-Chem, Inc. | 2002-01-18 | 179 | 0 |
| K012547 | HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION | Di-Chem, Inc. | 2002-01-18 | 164 | 1 |
| K905217 | FORMASURE TEST REAGENT | Di-Chem, Inc. | 1991-04-09 | 140 | 0 |
| K823103 | DIALYSATE ADDITIVES-POWDER/LIQUID | Di-Chem, Inc. | 1982-11-17 | 28 | 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