De Novo · Granted
GrantedNephrocheck Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astute Medical, Inc. · PIG Acute Kidney Injury Test System
Granted on Sep 5, 2014 as a new device type through De Novo after a 457-day review. 1 later device descends from it.
- Decided
- Sep 5, 2014
- Review
- 457 days
- Class
- Class II
- Product code
- PIG
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN130031 Nephrocheck Test SystemAstute Medical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK232761 ProNephro AKI™ (NGAL)Bioporto Diagnostic, Inc. · 2023 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K232761ProNephro AKI™ (NGAL)Bioporto Diagnostic, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN130031 | Nephrocheck Test System | Astute Medical, Inc. | 2014 | — |
| +1 | K232761 | ProNephro AKI™ (NGAL) | Bioporto Diagnostic, Inc. | 2023 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
Sources: FDA De Novo 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 PIG? 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 PIG device
- #1 K232761 ProNephro AKI™ (NGAL)score 4.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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 |
|---|---|---|---|
| K232761 | ProNephro AKI™ (NGAL) | 2023 | 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?
- Of its descendants, K232761 (Bioporto Diagnostic, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PIG devicesPIG Acute Kidney Injury Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PIG
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PIG
Too few PIG 510(k)s in any year since 2007 to give a median.
Recalls per year · PIG
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PIG
1in 2024
MAUDE reports naming product code PIG, 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 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Astute Medical NEPHROCHECK® Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are ICU patients as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment. The NEPHROCHECK® Test System is intended to be used in patients 21 years of age or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN130031 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN130031: Nephrocheck Test System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN130031
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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