Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Turpen Laboratory Systems, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
194 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K870836 | ATAC 1500 CHEMISTRY ANALYZER | Turpen Laboratory Systems, Inc. | 1987-04-01 | 29 | 0 |
| K863332 | ATAC 4300 HEMATOLOGY CELL COUNTER | Turpen Laboratory Systems, Inc. | 1986-09-29 | 33 | 0 |
| K851321 | ATAC 2000 CHEMISTRY ANALYZER | Turpen Laboratory Systems, Inc. | 1985-04-25 | 23 | 0 |
| K843059 | ATAC 2000 | Turpen Laboratory Systems, Inc. | 1984-10-11 | 69 | 0 |
| K832115 | ATAC 3000 | Turpen Laboratory Systems, Inc. | 1984-01-10 | 194 | 0 |
| K832116 | ATAC 4700 HEMATOLOGY CELL COUNTER | Turpen Laboratory Systems, Inc. | 1983-10-20 | 112 | 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