510(k) · Cleared
Recalled · Class II · 2024Healgen 11 Reagent Strip for Urinalysis, Healgen 10 Reagent Strip for Urinalysis, and Healgen 4 Reagent Strip for Urinal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healgen Scientific,, LLC · JIO Blood, Occult, Colorimetric, In Urine
Cleared on Apr 17, 2012 as substantially equivalent to K040703 (Dirui Industrial Co., Ltd., 2004) after a 279-day review. Its family tree reaches back 2 generations to 1986. It has been recalled once.
- Decided
- Apr 17, 2012
- Review
- 279 days
- Class
- Class II
- Product code
- JIO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K861255 (1986). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK861255 Behring Rapignost Total Screen L Urine Test StripsBehring Diagnostics, Inc. · 1986
- 1 generation backK040703 Uristik H Series Reagent Strips for UrinalysisDirui Industrial Co., Ltd. · 2004
- This deviceK111999 Healgen 11 Reagent Strip for Urinalysis, Healgen 10 Reagent Strip…Healgen Scientific,, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K861255 | Behring Rapignost Total Screen L Urine Test Strips | Behring Diagnostics, Inc. | 1986 | — |
| −1 | K040703 | Uristik H Series Reagent Strips for Urinalysis | Dirui Industrial Co., Ltd. | 2004 | — |
| 0 (this device) | K111999 | Healgen 11 Reagent Strip for Urinalysis, Healgen 10 Reagent Strip for… | Healgen Scientific,, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2000 | 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 JIO? 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 JIO device
- #1 K232317 UC-1800 Automatic Urine Analyzer, URIT 11FA…score 8.4 · 5 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 |
|---|---|---|---|
| * | K040703 | Uristik H Series Reagent Strips for UrinalysisSummary page 1…e Device: URISTK H Series Reagent Strips for Urinalysis and Dirui H-5O, H-1 00, or H-500 Urine Analyzer manufactured by Dirui Industrial Co. Ltd (K040703). Device Description Healgen Series Reagent strips for Urinalysis and urine analyzers are in vitro diagnost… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 22, 2024 | Class II | Z-3303-2024 | Nonconforming Material/Component | The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential false negative results for the detection of urinary protein by way of uneven color… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 17.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K040703.
How does its category compare?
All JIO devicesJIO Blood, Occult, Colorimetric, In Urine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JIO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JIO
Too few JIO 510(k)s in any year since 2007 to give a median.
Recalls per year · JIO
No recall names JIO since 2007.
Adverse event reports per year · JIO
1in 2025
MAUDE reports naming product code JIO, 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 | 2 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Healgen Series Urine Reagent Strips and Urine Analyzers are in-vitro test systems intended for qualitative and semi-quantitative analysis of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Nitrite, Leucocytes, Glucose, Specific gravity, pH and Ascorbic Acid in urine. The test systems consist of the Healgen Series Reagent. Strips (Healgen 10 and Healgen 11) and the Healgen 500 or Healgen 800 Urine Analyzers. The Healgen 10 and 11 strips can be read…
Read the full statement (169 words)
The Healgen Series Urine Reagent Strips and Urine Analyzers are in-vitro test systems intended for qualitative and semi-quantitative analysis of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Nitrite, Leucocytes, Glucose, Specific gravity, pH and Ascorbic Acid in urine. The test systems consist of the Healgen Series Reagent. Strips (Healgen 10 and Healgen 11) and the Healgen 500 or Healgen 800 Urine Analyzers. The Healgen 10 and 11 strips can be read visually and instrumentally with the Healgen 500 and 800 Analyzers. The Healgen 4 reagent strip can be read visually only. The Healgen Series Urine Reagent Strips and Urine Analyzers are intended for use to detect conditions indicating possible diabetes, metabolic abnormalities, liver diseases, kidney function, and urinary tract infections. Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.
The Healgen 500 and 800 Urine Analyzers use reflectance photometry to quantitate analyte values from urine samples when using the Healgen 10 and 11 reagent test strips.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111999 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111999: Healgen 11 Reagent Strip for Urinalysis, Healgen 10 Reagent Strip for Urinalysis, and Healgen 4 Reagent Strip for Urinal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111999
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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