Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
SENTINEL CH. SpA — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
199 daysmedian FDA review time
333 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242585 | Cystatin C | SENTINEL CH. SpA | 2025-05-16 | 259 | 0 |
| K211058 | Lp(a) Ultra | SENTINEL CH. SpA | 2022-12-22 | 622 | 0 |
| K193001 | Albumin BCP | SENTINEL CH. SpA | 2019-12-19 | 52 | 0 |
| K192118 | CRP Vario | SENTINEL CH. SpA | 2019-11-08 | 94 | 0 |
| K173833 | CRP Vario | SENTINEL CH. SpA | 2018-09-27 | 283 | 0 |
| K141728 | ACE CALIBRATOR | SENTINEL CH. SpA | 2014-07-28 | 32 | 0 |
| K102706 | CKMB UDR ASSAY | SENTINEL CH. SpA | 2011-08-19 | 333 | 0 |
| K083602 | KAPPA LIGHT CHAINS | SENTINEL CH. SpA | 2009-09-03 | 272 | 0 |
| K083601 | LAMBDA LIGHT CHAINS | SENTINEL CH. SpA | 2009-06-22 | 199 | 0 |
| K081533 | SENTINEL PLASMAPROTEINS CAL 3X | SENTINEL CH. SpA | 2008-06-25 | 23 | 0 |
| K073634 | MULTIGENT CREATININE (ENZYMATIC) ASSAY | SENTINEL CH. SpA | 2008-06-19 | 176 | 1 |
| K070987 | SENTINEL LITHIUM ASSAY | SENTINEL CH. SpA | 2007-08-02 | 118 | 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