Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
International Biomedics, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
119 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K031096 | MODIFICATION TO TRANSPORT INCUBATOR 185 | International Biomedics, Inc. | 2003-06-24 | 78 | 0 |
| K860933 | AIR-CUSHION TOCOTONOMETER | International Biomedics, Inc. | 1986-07-09 | 119 | 0 |
| K862072 | FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01 | International Biomedics, Inc. | 1986-07-09 | 40 | 0 |
| K860295 | FETASCAN 1500 | International Biomedics, Inc. | 1986-05-19 | 111 | 0 |
| K852439 | FETA SCAN 1000 OBSTETRICAL IMAGER | International Biomedics, Inc. | 1985-08-30 | 81 | 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