510(k) · Cleared
ClearedUritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine Analyzers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Urit Medical Electronic Co., Ltd. · JIO Blood, Occult, Colorimetric, In Urine
Cleared on Sep 11, 2009 as substantially equivalent to K926359 (Heraeus Kulzer, Inc., 1993) and 2 other predicates after a 352-day review. Its family tree reaches back 2 generations to 1986. 1 later device descends from it.
- Decided
- Sep 11, 2009
- Review
- 352 days
- Class
- Class II
- Product code
- JIO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K861255 (1986). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK082811 Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and…Urit Medical Electronic Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK232317 UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips…Urit Medical Electronic Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine…Urit Medical Electronic Co., Ltd. · 2024 · cites it directly0descendants
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) | K082811 | Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine… | Urit Medical Electronic Co., Ltd. | 2009 | — |
| +1 | K232317 | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA… | Urit Medical Electronic Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K926359 | Clinitek 200+ Urine Chemistry AnalyzerSummary page 1…al Chemistry (75) Product codes: KQO, JIL, JIP 21 CFR Part 862.2900 5. Predicate Device Information: Bayer Clinitek 500 Urine Chemistry Analyzer (K926359) Bayer Multistix 10O-SG Reagent Strips for Urinalysis (K052719) Dirui URISTK H-I I Reagent Strips and Dirui H-500 U… | 1993 |
| * | K052719 | Uritest 10 Urinalysis Reagent StripsSummary page 1…862.2900 5. Predicate Device Information: Bayer Clinitek 500 Urine Chemistry Analyzer (K926359) Bayer Multistix 10O-SG Reagent Strips for Urinalysis (K052719) Dirui URISTK H-I I Reagent Strips and Dirui H-500 Urine Analyzer (KO40703) Pag… | 2006 |
| * | K040703 | Uristik H Series Reagent Strips for Urinalysis | 2004 |
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 |
|---|---|---|---|
| K232317 | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine… | 2024 | 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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 17.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K232317 (Urit Medical Electronic Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K926359.
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. 2009, 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 Uritest-50 and Uritest-500B urine analyzers are semi-automated, bench top instruments which are intended for professional, in vitro diagnostic use only. Depending on the reagent strips being used, the instruments perform semi-quantitative detection of the following analytes in urine: leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid (Uritest 10G urine reagent strips don't have the…
Read the full statement (188 words)
The Uritest-50 and Uritest-500B urine analyzers are semi-automated, bench top instruments which are intended for professional, in vitro diagnostic use only.
Depending on the reagent strips being used, the instruments perform semi-quantitative detection of the following analytes in urine: leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid (Uritest 10G urine reagent strips don't have the ascorbic acid pad). Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. The instruments use the accompanying check strip for daily calibration.
Uritest 10G urine reagent strips provide semi-quantitative tests for leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood and pH in urine. The Uritest 10G urine reagent strips are for use with the Uritest-50 urine analyzer and are for professional, in vitro diagnostic use only.
Uritest 11 G urine reagent strips provide semi-quantitative tests for leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid in urine. The Uritest 11 G urine reagent strips are for use with Uritest-500B urine analyzer and are for professional, in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082811 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082811: Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine Analyzers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082811
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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