Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Technomics, Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
24 daysmedian FDA review time
78 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K844798 | EPPENDORF DILUTER | Medical Technomics, Ltd. | 1985-01-07 | 27 | 0 |
| K843608 | CAPILLARY BLOOD COLLECTION TUBE | Medical Technomics, Ltd. | 1984-11-30 | 78 | 0 |
| K843606 | PRECISION DISPENSER | Medical Technomics, Ltd. | 1984-09-21 | 8 | 0 |
| K843361 | MINICAPS | Medical Technomics, Ltd. | 1984-09-21 | 24 | 0 |
| K843607 | LABOPETTOR | Medical Technomics, Ltd. | 1984-09-21 | 8 | 0 |
| K843362 | RINGCAPS | Medical Technomics, Ltd. | 1984-09-21 | 24 | 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