SENTINEL CH. SpA: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “SENTINEL CH. SpA” (first 2007, latest 2025), across 12 product codes in 3 review panels. Median 510(k) review time under this name: 188 days. Since 2017 the median was 259 days, against 185 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 32 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 283 |
| 2019 | 2 | 73 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 622 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 259 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name SENTINEL CH. SpA took a median 259 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 185 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CJW | Bromcresol Purple Dye-Binding, Albumin | 1 | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| DEH | Lambda, Antigen, Antiserum, Control | 1 | 1 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 1 | 1 |
| DFH | Kappa, Antigen, Antiserum, Control | 1 | 1 |
| JFY | Enzymatic Method, Creatinine | 1 | 1 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 1 | 1 |
| JIT | Calibrator, Secondary | 1 | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 | 1 |
| NDW | Assay, Porphyrin, Spectrophotometry, Lithium | 1 | 1 |
Plus 2 more product codes.
Review panels
- Clinical Chemistry (6)
- Immunology (5)
- Clinical Toxicology (1)
Most recent SENTINEL CH. SpA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242585 | Cystatin C | NDY | 2025-05-16 | 259 |
| K211058 | Lp(a) Ultra | DFC | 2022-12-22 | 622 |
| K193001 | Albumin BCP | CJW | 2019-12-19 | 52 |
| K192118 | CRP Vario | DCK | 2019-11-08 | 94 |
| K173833 | CRP Vario | NQD | 2018-09-27 | 283 |
| K141728 | ACE CALIBRATOR | JIT | 2014-07-28 | 32 |
| K102706 | CKMB UDR ASSAY | JHS | 2011-08-19 | 333 |
| K083602 | KAPPA LIGHT CHAINS | DFH | 2009-09-03 | 272 |
| K083601 | LAMBDA LIGHT CHAINS | DEH | 2009-06-22 | 199 |
| K081533 | SENTINEL PLASMAPROTEINS CAL 3X | JIX | 2008-06-25 | 23 |
2 earlier clearances. See the full list in Caduvo.
Recalls
8 product recalls in 6 recall events; 2 initiated in the last five years. Most recent: 2023-09-29.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sentinel Ch. Srl (10 510(k)s)
- Sentinel Medical Technologies, LLC (2 510(k)s)
- Sentinel (1 510(k)s)
- Sentinel Medical, Inc. (1 510(k)s)
- Sentinel Medical Technologies, (1 510(k)s)
- Sentinel Monitoring Technologies, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under SENTINEL CH. SpA?
FDA lists 12 510(k) clearances under the applicant name “SENTINEL CH. SpA” (first 2007, latest 2025), across 12 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by SENTINEL CH. SpA?
The median time from FDA receipt to decision across 510(k)s cleared under the name SENTINEL CH. SpA is 188 days. Since 2017: 259 days, versus 185 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under SENTINEL CH. SpA?
The most frequent FDA product codes under this applicant name are CJW (Bromcresol Purple Dye-Binding, Albumin, 1); DCK (C-Reactive Protein, Antigen, Antiserum, And Control, 1); DEH (Lambda, Antigen, Antiserum, Control, 1).
Next steps
- See all 12 SENTINEL CH. SpA clearances with predicates and recalls
- Run predicate analysis for product code CJW, SENTINEL CH. SpA's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.