Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Infarkem Corp. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K852606 | FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20) | Infarkem Corp. | 1985-09-19 | 92 | 0 |
| K851236 | HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES | Infarkem Corp. | 1985-07-26 | 121 | 0 |
| K851336 | IV/0165 INFUSION SET | Infarkem Corp. | 1985-05-30 | 57 | 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