Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
International Biomedical, Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
135 daysmedian FDA review time
161 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103525 | A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPO | International Biomedical, Ltd. | 2011-05-11 | 161 | 0 |
| K103523 | 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPO | International Biomedical, Ltd. | 2011-05-11 | 161 | 0 |
| K103524 | VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRA | International Biomedical, Ltd. | 2011-04-15 | 135 | 0 |
| K103527 | AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRA | International Biomedical, Ltd. | 2011-04-15 | 135 | 0 |
| K093260 | AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM | International Biomedical, Ltd. | 2009-12-16 | 58 | 0 |
| K081399 | AVIATOR TRANSPORT INCUBATOR | International Biomedical, Ltd. | 2008-06-06 | 18 | 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