Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Western Laboratories Corp. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
202 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K834024 | HEPARINOMETER | Western Laboratories Corp. | 1984-06-11 | 202 | 0 |
| K830468 | MODEL 200 | Western Laboratories Corp. | 1983-04-12 | 56 | 0 |
| K821834 | MODEL 100 BICARBONATE CONDUCTIVITY | Western Laboratories Corp. | 1982-07-02 | 10 | 0 |
| K821414 | MODEL 80 BC | Western Laboratories Corp. | 1982-05-27 | 15 | 0 |
| K821415 | MODEL 90 BC | Western Laboratories Corp. | 1982-05-27 | 15 | 0 |
| K801303 | MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST | Western Laboratories Corp. | 1980-07-28 | 55 | 0 |
| K780932 | MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT | Western Laboratories Corp. | 1978-08-31 | 86 | 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