510(k) · Cleared
ClearedBlood Collection Tube Samples for Use with Point of Care Blood Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epocal, Inc. · CEM Electrode, Ion Specific, Potassium
Cleared on Mar 30, 2010 as substantially equivalent to K001387 (I-Stat Corp., 2000) after a 195-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Mar 30, 2010
- Review
- 195 days
- Class
- Class II
- Product code
- CEM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001387 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK001387 I-Stat Portable Clinical Analyzer, Model 300I-Stat Corp. · 2000 · Recalled
- This deviceK092849 Blood Collection Tube Samples for Use with Point of Care Blood…Epocal, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK200107 epoc Blood Analysis SystemEpocal, Inc. · 2020 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K200107epoc Blood Analysis SystemEpocal, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001387 | I-Stat Portable Clinical Analyzer, Model 300 | I-Stat Corp. | 2000 | 13 |
| 0 (this device) | K092849 | Blood Collection Tube Samples for Use with Point of Care Blood Analyzer | Epocal, Inc. | 2010 | — |
| +1 | K200107 | epoc Blood Analysis System | Epocal, Inc. | 2020 | 19 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 CEM? 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 CEM device
- #1 K253491 ISE indirect K for Gen.2; ISE indirect Na for…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? (1)
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 |
|---|---|---|---|
| * | K001387 | I-Stat Portable Clinical Analyzer, Model 300Summary page 3…is System I-STAT Model 300 510(k) #K061597 and K090109 K001387 . .Sa… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200107 | epoc Blood Analysis System | 2020 | 0 |
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.
What does this lineage say?
How does its category compare?
All CEM devicesCEM Electrode, Ion Specific, Potassium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · CEM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CEM
180in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEM
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEM
29in 2025
MAUDE reports naming product code CEM, 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 | 66 |
| 2008 | 0 | — | 1 | 245 |
| 2009 | 1 | — | 0 | 79 |
| 2010 | 3 | 195 | 12 | 113 |
| 2011 | 3 | 74 | 6 | 126 |
| 2012 | 4 | 180 | 0 | 45 |
| 2013 | 0 | — | 0 | 37 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 32 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 1 | 25 |
| 2020 | 1 | — | 3 | 27 |
| 2021 | 0 | — | 1 | 18 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 2 | — | 2 | 30 |
| 2024 | 0 | — | 0 | 42 |
| 2025 | 1 | — | 4 | 29 |
| 2026 | 1 | — | 0 | — |
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 in hospitals, nursing homes or other clinical care institutions. Care-Fill Capillary Tubes are intended for use with the epoc Blood Analysis system and are used for the collection…
Read the full statement (250 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 in hospitals, nursing homes or other clinical care institutions.
Care-Fill Capillary Tubes are intended for use with the epoc Blood Analysis system and are used for the collection and dispensing of capillary blood samples with epoc Test Cards.
The Blood Gas Electrolyte (BUE) test card panel configuration includes sensors for Sodium - Na, Potassium - K, Calcium - iCa, pH, pCO2, pO2 and Hematocrit - Hct.
The Blood Gas Electrolyte (BGEM) test card panel configuration includes sensors for Sodium - Na, Potassium - K, Calcium - iCa, pH, pCO2, pO2, Hematocrit - Hct and Glucose - Glu.
Measurement of sodium is used in diagnosis and treatment of diseases involving electrolyte imbalance.
Measurement of potassium is used in diagnosis and treatment of diseases involving electrolyte imbalance.
Measurement of Ionized Calcium is used in diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Measurement of pH, pCO2, pO2 (blood gases) is used in the diagnosis and treatment of life-threatening acid-base disturbances.
Measurement of Hct distinguishes normal from abnormal states of blood volume, such as anemia and erythrocytosis.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia, and of pancreatic islet cell tumors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092849 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092849: Blood Collection Tube Samples for Use with Point of Care Blood Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092849
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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