Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
CHW · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192730 | CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV | Biosystems S.A. | 2020-09-09 | 348 | 0 |
| K113521 | CALCIUM GEN. 2 | Roche Diagnostics | 2012-05-08 | 161 | 0 |
| K781454 | LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA | Union Carbide Corp. | 1978-09-20 | 29 | 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