Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vital Diagnostics (Manufacturing) Ptyltd — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
118 daysmedian FDA review time
338 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120626 | EON CALCIUM REGENT | Vital Diagnostics (Manufacturing) Ptyltd | 2012-08-22 | 174 | 2 |
| K112416 | CPK REAGENT | Vital Diagnostics (Manufacturing) Ptyltd | 2011-11-09 | 79 | 0 |
| K111063 | VITAL SERUM CONTROLS | Vital Diagnostics (Manufacturing) Ptyltd | 2011-06-28 | 71 | 0 |
| K110394 | ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) | Vital Diagnostics (Manufacturing) Ptyltd | 2011-06-09 | 118 | 0 |
| K100060 | EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONA | Vital Diagnostics (Manufacturing) Ptyltd | 2010-12-15 | 338 | 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