Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Astral Medical Systems · 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) |
|---|---|---|---|---|---|
| K900506 | MODIFIED COATRON II AND COATRON JR. | Astral Medical Systems | 1990-03-12 | 38 | 0 |
| K851153 | COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE | Astral Medical Systems | 1985-11-05 | 228 | 0 |
| K853734 | APOLLO DENSITOMETER | Astral Medical Systems | 1985-09-25 | 19 | 0 |
| K851154 | ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18 | Astral Medical Systems | 1985-05-13 | 52 | 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