Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sparta Instrument Corp. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K854475 | GHAJAR INTRAVENTRICULAR CATHETER GUIDE | Sparta Instrument Corp. | 1986-02-20 | 105 | 0 |
| K781365 | SPARTA BRONCHIAL BRUSH | Sparta Instrument Corp. | 1978-08-14 | 7 | 0 |
| K780258 | MILK BATH CONCENTRATE | Sparta Instrument Corp. | 1978-06-13 | 118 | 0 |
| K780257 | MICROSPEARS | Sparta Instrument Corp. | 1978-02-23 | 8 | 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