Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Linton Biomed Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
17 daysmedian FDA review time
67 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841772 | HEPARIN CAP, INJECTION CAP MALE LUER- | Linton Biomed Corp. | 1984-07-06 | 67 | 0 |
| K831348 | FLUID ADMIN. SET AFS-1C | Linton Biomed Corp. | 1983-05-27 | 32 | 0 |
| K820202 | CONTINUOUS FLUSH DEVICE/FDI | Linton Biomed Corp. | 1982-02-12 | 17 | 0 |
| K820201 | DISPOS. MONITORING SYS/LI ET AL | Linton Biomed Corp. | 1982-02-12 | 17 | 0 |
| K820203 | FLUID ADMINISTRATIVE SET, AFI | Linton Biomed Corp. | 1982-02-05 | 10 | 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