510(k) · Cleared
Clearedepoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epocal, Inc. · CDS Electrode, Ion Specific, Urea Nitrogen
Cleared on Jan 17, 2018 as substantially equivalent to K053110 (I-Stat Corporation, 2006) after a 264-day review. Its family tree reaches back 1 generation to 2006. 1 later device descends from it.
- Decided
- Jan 17, 2018
- Review
- 264 days
- Class
- Class II
- Product code
- CDS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053110 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK053110 Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott…I-Stat Corporation · 2006 · Recalled
- This deviceK171247 epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestEpocal, Inc. · 2018
- 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 | K053110 | Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+… | I-Stat Corporation | 2006 | 3 |
| 0 (this device) | K171247 | epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test | Epocal, Inc. | 2018 | — |
| +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 CDS? 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 |
|---|---|---|---|
| * | K053110 | Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge…Summary page 4…Electrode, Ion Specific, Urea Nitrogen JFL pH Rate Measurement, Carbon-Dioxide Predicate Device: i-STAT CHEM8+ Cartridge (K053110; cleared by i-STAT Corporation) DEVICE DESCRIPTION The epoc Blood Analysis System is an in vitro… | 2006 |
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?
- Its one ancestor has a recall.
- Of its descendants, K200107 (Epocal, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CDS devicesCDS Electrode, Ion Specific, Urea Nitrogen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · CDS
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · CDS
Too few CDS 510(k)s in any year since 2007 to give a median.
Recalls per year · CDS
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDS
1in 2022
MAUDE reports naming product code CDS, 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 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Blood Urea Nitrogen and Total Carbon Dioxide tests, 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.
Blood Urea Nitrogen measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal and metabolic diseases.
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171247: epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171247
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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