Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Baker Instructions Corp. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
90 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K882612 | SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER | Baker Instructions Corp. | 1988-09-07 | 75 | 0 |
| K873596 | BAKER TDM THEOPHYLLINE ASSAY | Baker Instructions Corp. | 1987-10-20 | 46 | 0 |
| K870603 | SYSTEM 9000 AUTOMATED CELL COUNTER | Baker Instructions Corp. | 1987-03-31 | 48 | 0 |
| K854173 | UCD URINE SPECIMEN COLLECTOR | Baker Instructions Corp. | 1985-11-04 | 20 | 0 |
| K850386 | SYSTEM 8000 CELL COUNTER | Baker Instructions Corp. | 1985-05-02 | 90 | 0 |
| K833116 | SPIRIT CHEMISTRY SYSTEM | Baker Instructions Corp. | 1983-11-07 | 55 | 0 |
| K832716 | ENCORE CHEMISTRY ANALYZER | Baker Instructions Corp. | 1983-10-04 | 53 | 0 |
| K830641 | ENCORE CHEMISTRY ANALYZER | Baker Instructions Corp. | 1983-04-05 | 35 | 0 |
| K821956 | HAEM-C PLUS BLOOD REFERENCE CONTROLS | Baker Instructions Corp. | 1982-07-30 | 30 | 0 |
| K811694 | CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT | Baker Instructions Corp. | 1981-07-01 | 16 | 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