Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Australian Biomedical Corporation , Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
153 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K871735 | VOROSCOPE(TM) | Australian Biomedical Corporation , Ltd. | 1987-06-03 | 29 | 0 |
| K862457 | LYNX EL MICROSCOPY TISSUE PROCESSOR | Australian Biomedical Corporation , Ltd. | 1986-07-16 | 16 | 0 |
| K851660 | DONWAY LIFTING FRAME | Australian Biomedical Corporation , Ltd. | 1985-08-07 | 106 | 0 |
| K853114 | ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR | Australian Biomedical Corporation , Ltd. | 1985-08-06 | 13 | 0 |
| K843522 | DONWAY SPLINT | Australian Biomedical Corporation , Ltd. | 1985-02-07 | 153 | 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