510(k) · Cleared
ClearedMinuteful-kidney test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthy.Io, Ltd. · JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Cleared on Sep 8, 2023 as substantially equivalent to K210069 (Healthy.Io, Ltd., 2022) after a 347-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Sep 8, 2023
- Review
- 347 days
- Class
- Class I
- Product code
- JIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K905396 (1991). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK905396 Hemastix Reagent StripsHeraeus Kulzer, Inc. · 1991
- 4 generations backK031947 Bayer Clinitek Status AnalyzerBayer Healthcare, LLC · 2003
- 3 generations backK091216 Clinitek Status+Analyzer and Clinitek Status Connect System, Models…Siemens Healthcare Diagnostics · 2009 · Recalled
- 2 generations backK141874 Uriscan OptimaYd Diagnostics Corp. · 2015
- 1 generation backK210069 Minuteful - kidney testHealthy.Io, Ltd. · 2022
- This deviceK222921 Minuteful-kidney testHealthy.Io, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K905396 | Hemastix Reagent Strips | Heraeus Kulzer, Inc. | 1991 | — |
| −4 | K031947 | Bayer Clinitek Status Analyzer | Bayer Healthcare, LLC | 2003 | — |
| −3 | K091216 | Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 | Siemens Healthcare Diagnostics | 2009 | 4 |
| −2 | K141874 | Uriscan Optima | Yd Diagnostics Corp. | 2015 | — |
| −1 | K210069 | Minuteful - kidney test | Healthy.Io, Ltd. | 2022 | — |
| 0 (this device) | K222921 | Minuteful-kidney test | Healthy.Io, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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 JIR? 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 JIR device
- #1 K210069 Minuteful - kidney testscore 7.5 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K210069 | Minuteful - kidney testSummary page 5…ufacturer Device 510(k) Number Healthy.io Ltd. Minuteful - kidney test K210069 Device Description: The Minuteful - kidney test is comprised of a kit and a smartphone application. It is intended for the s… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 32 years and passes through 5 companies; a new generation was cleared every 5.8 years on median.
- 3 of the 11 ancestors have a recall of any class.
How does its category compare?
All JIR devicesJIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · JIR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JIR
Too few JIR 510(k)s in any year since 2007 to give a median.
Recalls per year · JIR
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIR
2in 2025
MAUDE reports naming product code JIR, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The system consists of a smartphone application, proprietary Color-Board and an ACR Reagent Strip. The system is available for prescription-use only and is intended for people at risk of kidney disease. Results are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222921: Minuteful-kidney test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222921
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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