Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Infab Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
60 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K900970 | RADIATION PROTECTION GLASSES | Infab Corp. | 1990-05-01 | 60 | 0 |
| K900972 | RADIATION PROTECTION GLOVES | Infab Corp. | 1990-05-01 | 60 | 0 |
| K901014 | RADIOGRAPHIC INTENSIFYING SCREEN | Infab Corp. | 1990-04-02 | 28 | 0 |
| K901013 | RADIOGRAPHIC FILM CASSETTE | Infab Corp. | 1990-03-28 | 23 | 0 |
| K901012 | RADIOGRAPHIC GRID | Infab Corp. | 1990-03-28 | 23 | 0 |
| K896289 | RADIATION PROTECTION APRON | Infab Corp. | 1989-12-14 | 44 | 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