Sentinel Ch. Srl: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Sentinel Ch. Srl” (first 2005, latest 2007), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 135 days. 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 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | 3 | 3 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| DIH | Colorimetry, Cholinesterase | 1 | 1 |
| JFJ | Catalytic Methods, Amylase | 1 | 1 |
| JFR | Indirect Copper Assay, Ceruloplasmin | 1 | 1 |
| JIF | Enzymatic Method, Ammonia | 1 | 1 |
| JIY | Photometric Method, Iron (Non-Heme) | 1 | 1 |
| JQF | Bathophenanthroline, Iron Binding Capacity | 1 | 1 |
Review panels
- Clinical Chemistry (7)
- Immunology (2)
- Clinical Toxicology (1)
Most recent Sentinel Ch. Srl 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070971 | MODIFICATION TO SENTINEL CLIN CHEM CAL | JIX | 2007-05-23 | 47 |
| K051447 | SENTINEL PANCREATIC AMYLASE | JFJ | 2006-01-26 | 238 |
| K051114 | SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY | JIF | 2005-11-25 | 207 |
| K051111 | SENTINEL UIBC LIQUID | JQF | 2005-11-17 | 199 |
| K051452 | SENTINEL CLIN CHEM CAL | JIX | 2005-10-25 | 145 |
| K051456 | SENTINEL CERULOPLASMIN | JFR | 2005-10-21 | 141 |
| K051115 | SENTINEL IRON LIQUID | JIY | 2005-08-25 | 115 |
| K050836 | CRP DIAGNOSTIC ASSAY | DCK | 2005-08-08 | 129 |
| K051457 | SENTINEL PLASMAPROTEINS CAL 3X | JIX | 2005-07-25 | 53 |
| K051444 | SENTINEL CHOLINESTERASE LIQUID | DIH | 2005-06-20 | 18 |
Recalls
openFDA lists no recalls under a recalling firm named Sentinel Ch. Srl.
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. SpA (12 510(k)s)
- Sentinel Medical Technologies, LLC (3 510(k)s)
- Sentinel (1 510(k)s)
- Sentinel Medical, Inc. (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. Srl?
FDA lists 10 510(k) clearances under the applicant name “Sentinel Ch. Srl” (first 2005, latest 2007), across 8 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. Srl?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sentinel Ch. Srl is 135 days.
Which FDA product codes appear under Sentinel Ch. Srl?
The most frequent FDA product codes under this applicant name are JIX (Calibrator, Multi-Analyte Mixture, 3); DCK (C-Reactive Protein, Antigen, Antiserum, And Control, 1); DIH (Colorimetry, Cholinesterase, 1).
Next steps
- See all 10 Sentinel Ch. Srl clearances with predicates and recalls
- Run predicate analysis for product code JIX, Sentinel Ch. Srl'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.