Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Advanced Biomedical Instruments — 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) |
|---|---|---|---|---|---|
| K843156 | BIOLAS YAG 100 CILAS, ERCELAS YAG 100 | Advanced Biomedical Instruments | 1984-10-01 | 52 | 0 |
| K842670 | BIOLAS YAG 100 | Advanced Biomedical Instruments | 1984-08-08 | 29 | 0 |
| K820519 | BIOPSER | Advanced Biomedical Instruments | 1982-04-29 | 63 | 0 |
| K801197 | CO2 LASER | Advanced Biomedical Instruments | 1980-06-30 | 42 | 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