Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sentinel Ch. Srl — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
141 daysmedian FDA review time
238 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070971 | MODIFICATION TO SENTINEL CLIN CHEM CAL | Sentinel Ch. Srl | 2007-05-23 | 47 | 0 |
| K051447 | SENTINEL PANCREATIC AMYLASE | Sentinel Ch. Srl | 2006-01-26 | 238 | 0 |
| K051114 | SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY | Sentinel Ch. Srl | 2005-11-25 | 207 | 1 |
| K051111 | SENTINEL UIBC LIQUID | Sentinel Ch. Srl | 2005-11-17 | 199 | 0 |
| K051452 | SENTINEL CLIN CHEM CAL | Sentinel Ch. Srl | 2005-10-25 | 145 | 0 |
| K051456 | SENTINEL CERULOPLASMIN | Sentinel Ch. Srl | 2005-10-21 | 141 | 0 |
| K051115 | SENTINEL IRON LIQUID | Sentinel Ch. Srl | 2005-08-25 | 115 | 0 |
| K050836 | CRP DIAGNOSTIC ASSAY | Sentinel Ch. Srl | 2005-08-08 | 129 | 0 |
| K051457 | SENTINEL PLASMAPROTEINS CAL 3X | Sentinel Ch. Srl | 2005-07-25 | 53 | 1 |
| K051444 | SENTINEL CHOLINESTERASE LIQUID | Sentinel Ch. Srl | 2005-06-20 | 18 | 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