Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FLB · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
475 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100237 | DIALYSATE METER, MODEL D-6 | Myron L Company | 2010-04-23 | 87 | 0 |
| K925210 | 90DX MULTITEST METER, MODIFICATION | Mesa Medical, Inc. | 1994-01-25 | 475 | 0 |
| K882032 | MODEL 90DX MULTITEST METER | Mesa Medical, Inc. | 1988-08-11 | 87 | 0 |
| K830629 | COBE RX METER | Cobe Laboratories, Inc. | 1983-04-06 | 36 | 0 |
| K821415 | MODEL 90 BC | Western Laboratories Corp. | 1982-05-27 | 15 | 0 |
| K770263 | DIALYSATE METER RS-2100A, CIRCUIT CHANGE | Renal Systems, Inc. | 1977-02-18 | 7 | 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