Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medprobe Laboratories — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K833816 | HEMASTICK 1-1.5 & 2-DISPOS. BLOOD | Medprobe Laboratories | 1983-12-22 | 50 | 0 |
| K830001 | SUPERJET BTD BLEEDING TIME DEVICE DISP | Medprobe Laboratories | 1983-09-26 | 266 | 0 |
| K830010 | SUPERJET LANCET | Medprobe Laboratories | 1983-01-26 | 0 | 0 |
| K820625 | HEMALET AUTOMATIC LANCET DEVICE | Medprobe Laboratories | 1982-04-09 | 32 | 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