510(k) · Cleared
ClearedDatapro Clinical Chelistry Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Electron Corporation · CFR Hexokinase, Glucose
Cleared on Apr 27, 2005 after a 204-day review. The FDA summary names no predicate by number.
- Decided
- Apr 27, 2005
- Review
- 204 days
- Class
- Class II
- Product code
- CFR
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CFR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CFR device
- #1 K253490 Glucose HK Gen.3; ONLINE DAT Methadone II…score 11.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All CFR devicesCFR Hexokinase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CFR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CFR
115in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CFR
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFR
16in 2025
MAUDE reports naming product code CFR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 5 | 182 | 7 | 2 |
| 2009 | 3 | 101 | 1 | 7 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 3 | 316 | 0 | 43 |
| 2012 | 4 | 115 | 1 | 49 |
| 2013 | 1 | — | 0 | 36 |
| 2014 | 1 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 2 | — | 1 | 1 |
| 2017 | 1 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 1 | — | 0 | 16 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The DataProTM/DataPro PlusTM Clinical Chemistry Analyzer is a fully automated clinical chemistry analyzer intended for routine diagnostic clinical laboratory use. The DataProTM has replaceable parts, automated maintenance monitoring and backup of both patient and system data. With a throughput of up to 230 tests per hour, the DataProTM is intended for small and medium-sized laboratories, or as a backup analyzer in large volume laboratories. The DataPro…
Read the full statement (161 words)
The DataProTM/DataPro PlusTM Clinical Chemistry Analyzer is a fully automated clinical chemistry analyzer intended for routine diagnostic clinical laboratory use. The DataProTM has replaceable parts, automated maintenance monitoring and backup of both patient and system data. With a throughput of up to 230 tests per hour, the DataProTM is intended for small and medium-sized laboratories, or as a backup analyzer in large volume laboratories.
The DataPro TM/DataPro PtusTM Clinical Chemistry Analyzer is intended to be used in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae related to the measurement of various clinical assays, such as Albumin, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Urea Nitrogen (BUN), Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, Phosphorus, Total Bilirubin, Total Protein, Triglyceride, and Uric Acid.
The DataProTM , and all of the reagents included in this test system are for in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042767 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042767: Datapro Clinical Chelistry Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042767
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026