510(k) · Cleared
Recalled · Class II · 2026epoc Blood Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epocal, Inc. · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Jun 5, 2020 as substantially equivalent to K061597 (Epocal, Inc., 2006) and 4 other predicates after a 140-day review. Its family tree reaches back 3 generations to 2000. It has been recalled 19 times.
- Decided
- Jun 5, 2020
- Review
- 140 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 19
- Predicates
- 5
Its longest line of descent runs back 3 generations to K003261 (2000). 9 ancestors in all, the oldest K001387 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK003261 Creatinine PlusRoche Diagnostics Corp. · 2000 · Recalled
- 2 generations backK024098 Cobas Integra Creatinine Plus Ver.2 AssayRoche Diagnostics Corp. · 2002 · Recalled
- 1 generation backK113726 Epoc Chloride Test and Epoc Creatinine TestEpocal, Inc. · 2012
- This deviceK200107 epoc Blood Analysis SystemEpocal, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003261 | Creatinine Plus | Roche Diagnostics Corp. | 2000 | 1 |
| −2 | K024098 | Cobas Integra Creatinine Plus Ver.2 Assay | Roche Diagnostics Corp. | 2002 | 2 |
| −1 | K113726 | Epoc Chloride Test and Epoc Creatinine Test | Epocal, Inc. | 2012 | — |
| 0 (this device) | K200107 | epoc Blood Analysis System | Epocal, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 2 | 0 |
| 2018 | 1 | 0 |
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 CHL? 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 CHL device
- #1 K252207 ABL90 FLEX PLUS System, safeCLINITUBESscore 14.2 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061597 | Epoc Blood Analysis SystemSummary page 6…e (Lact), Creatinine (Crea), Hematocrit (Hct), Blood Urea Nitrogen (BUN) and Total Carbon Dioxide (TCO2) in arterial, venous, and capillary blood samples per k061597, k090109, k092849, k093297, k113726 and k171247. This Special 510(k) submission has been prepared to introduce hardw… | 2006 |
| * | K092849 | Blood Collection Tube Samples for Use with Point of Care Blood AnalyzerSummary page 6…ne (Crea), Hematocrit (Hct), Blood Urea Nitrogen (BUN) and Total Carbon Dioxide (TCO2) in arterial, venous, and capillary blood samples per k061597, k090109, k092849, k093297, k113726 and k171247. This Special 510(k) submission has been prepared to introduce hardware and software… | 2010 |
| * | K093297 | Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary TubeSummary page 6…(Crea), Hematocrit (Hct), Blood Urea Nitrogen (BUN) and Total Carbon Dioxide (TCO2) in arterial, venous, and capillary blood samples per k061597, k090109, k092849, k093297, k113726 and k171247. This Special 510(k) submission has been prepared to introduce hardware and software upda… | 2010 |
| * | K113726 | Epoc Chloride Test and Epoc Creatinine TestSummary page 6…rit (Hct), Blood Urea Nitrogen (BUN) and Total Carbon Dioxide (TCO2) in arterial, venous, and capillary blood samples per k061597, k090109, k092849, k093297, k113726 and k171247. This Special 510(k) submission has been prepared to introduce hardware and software updates to the curr… | 2012 |
| * | K171247 | epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestSummary page 6…lood Urea Nitrogen (BUN) and Total Carbon Dioxide (TCO2) in arterial, venous, and capillary blood samples per k061597, k090109, k092849, k093297, k113726 and k171247. This Special 510(k) submission has been prepared to introduce hardware and software updates to the current epoc® Ho… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 2, 2026 | Class II | Z-2005-2026 | Under Investigation by firm | Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading… |
| Jul 7, 2025 | Class II | Z-2272-2025 | Under Investigation by firm | Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L. The maximum bias… |
| Mar 19, 2025 | Class II | Z-1684-2025 | Process control | The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n. |
| Mar 19, 2025 | Class II | Z-1685-2025 | Process control | The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n. |
| Nov 22, 2024 | Class II | Z-0741-2025 | Software design | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement… |
| Nov 22, 2024 | Class II | Z-0734-2025 | Software design | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement… |
| Nov 22, 2024 | Class II | Z-0736-2025 | Software design | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement… |
| Nov 22, 2024 | Class II | Z-0735-2025 | Software design | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement… |
| Nov 22, 2024 | Class II | Z-0737-2025 | Software design | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement… |
| Nov 22, 2024 | Class II | Z-0740-2025 | Software design | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement… |
| Nov 22, 2024 | Class II | Z-0738-2025 | Software design | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement… |
| Nov 22, 2024 | Class II | Z-0739-2025 | Software design | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement… |
| Sep 24, 2024 | Class II | Z-0286-2025 | Under Investigation by firm | Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10… |
| Oct 19, 2023 | Class II | Z-0601-2024 | Software design | Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS Host and Delete Blood… |
| Jun 1, 2023 | Class II | Z-2476-2023 | Under Investigation by firm | There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range. |
| Jun 1, 2023 | Class II | Z-2477-2023 | Under Investigation by firm | There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range. |
| Jun 1, 2023 | Class II | Z-2478-2023 | Under Investigation by firm | There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range. |
| Dec 12, 2022 | Class II | Z-1215-2023 | Under Investigation by firm | pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure |
| Aug 28, 2020 | Class II | Z-2970-2020 | Process control | Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia. |
The 5 latest of 19 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
- 6 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K061597.
How does its category compare?
All CHL devicesCHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · CHL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHL
267in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHL
13so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHL
210in 2025
MAUDE reports naming product code CHL, 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 | — | 6 | 16 |
| 2008 | 1 | — | 5 | 40 |
| 2009 | 0 | — | 6 | 74 |
| 2010 | 1 | — | 7 | 20 |
| 2011 | 4 | 108 | 1 | 50 |
| 2012 | 4 | 65 | 9 | 64 |
| 2013 | 5 | 152 | 1 | 62 |
| 2014 | 3 | 68 | 1 | 93 |
| 2015 | 4 | 155 | 3 | 55 |
| 2016 | 3 | 306 | 1 | 118 |
| 2017 | 1 | — | 1 | 206 |
| 2018 | 1 | — | 3 | 174 |
| 2019 | 0 | — | 0 | 141 |
| 2020 | 4 | 100 | 2 | 117 |
| 2021 | 2 | — | 0 | 147 |
| 2022 | 0 | — | 0 | 138 |
| 2023 | 5 | 267 | 4 | 177 |
| 2024 | 1 | — | 9 | 196 |
| 2025 | 1 | — | 0 | 210 |
| 2026 | 1 | — | 13 | — |
What is it indicated for?
The epoc Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous, or capillary whole blood in the laboratory or at the point of care. The Blood Gas Electrolyte and Metabolite (BGEM) Test Card panel configuration includes sensors that quantitate pH, pCO2, pO2, Sodium, Potassium, Ionized Calcium, Chloride, Total…
Read the full statement (330 words)
The epoc Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous, or capillary whole blood in the laboratory or at the point of care.
The Blood Gas Electrolyte and Metabolite (BGEM) Test Card panel configuration includes sensors that quantitate pH, pCO2, pO2, Sodium, Potassium, Ionized Calcium, Chloride, Total Carbon Dioxide, Glucose, Lactate, Blood Urea Nitrogen, Creatinine, and Hematocrit.
pH, pCO2, pO2 (blood gases) measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Sodium and Potassium measurements from the epoc Blood Analysis System are used in diagnosis and treatment of diseases involving electrolyte imbalance.
Ionized Calcium measurements from the epoc Blood Analysis System are used in diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Chloride measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of electrolyte and metabolic disorders.
Total Carbon Dioxide measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of disorders associated with changes in body acid-base balance.
Glucose measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell tumors.
Lactate measurements from the epoc Blood Analysis System are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
Blood Urea Nitrogen measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal and metabolic diseases.
Creatinine measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal diseases and in monitoring renal dialysis.
Hematocrit measurements from the epoc Blood Analysis System are used to distinguish normal from abnormal states of blood volume, such as anemia and erythrocytosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200107 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200107: epoc Blood Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200107
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026