510(k) · Cleared
Recalled · Class II · 2013Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epocal, Inc. · KHP Acid, Lactic, Enzymatic Method
Cleared on Jun 9, 2010 as substantially equivalent to K001387 (I-Stat Corp., 2000) after a 231-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it. It has been recalled once.
- Decided
- Jun 9, 2010
- Review
- 231 days
- Class
- Class I
- Product code
- KHP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001387 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK001387 I-Stat Portable Clinical Analyzer, Model 300I-Stat Corp. · 2000 · Recalled
- This deviceK093297 Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary TubeEpocal, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK200107 epoc Blood Analysis SystemEpocal, Inc. · 2020 · Recalled
- Descendant · cites it directly · 0 of its ownK200492 i-STAT CG4+ Cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView 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) | K093297 | Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary Tube | Epocal, Inc. | 2010 | — |
| +1 | K200107 | epoc Blood Analysis System | Epocal, Inc. | 2020 | 19 |
| +1 | K200492 | i-STAT CG4+ Cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 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 KHP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 2…haracteristics To Predicate Device . . ~~epoc Blo1od Analysis System i-STAT Model 300 510(k) # To be determined K001387 Same! Item Device Predicate… | 2000 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 13, 2013 | Class II | Z-1971-2013 | Nonconforming Material/Component | This recall is being initiated because the affected lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end of the Glucose test sensor (>400 mg/dl).… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KHP devicesKHP Acid, Lactic, Enzymatic Method: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KHP
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · KHP
Too few KHP 510(k)s in any year since 2007 to give a median.
Recalls per year · KHP
3in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHP
9in 2025
MAUDE reports naming product code KHP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 12 |
| 2014 | 0 | — | 1 | 19 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 3 | 41 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 13 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Lactate test, as part of 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.
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093297 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093297: Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093297
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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