510(k) · Cleared
ClearedMission U500 Urine Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · JIO Blood, Occult, Colorimetric, In Urine
Cleared on Jan 18, 2012 as substantially equivalent to K070929 (ACON Laboratories, Inc., 2007) after a 261-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.
- Decided
- Jan 18, 2012
- Review
- 261 days
- Class
- Class II
- Product code
- JIO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K905396 (1991). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK905396 Hemastix Reagent StripsHeraeus Kulzer, Inc. · 1991
- 2 generations backK031947 Bayer Clinitek Status AnalyzerBayer Healthcare, LLC · 2003
- 1 generation backK070929 Acon U120 Urine Analyzer, Model U111-101ACON Laboratories, Inc. · 2007
- This deviceK111221 Mission U500 Urine AnalyzerACON Laboratories, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK173327 DIP/U.S. Urine Analysis Test SystemHealthy.Io, Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K173327DIP/U.S. Urine Analysis Test SystemHealthy.Io, Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K905396 | Hemastix Reagent Strips | Heraeus Kulzer, Inc. | 1991 | — |
| −2 | K031947 | Bayer Clinitek Status Analyzer | Bayer Healthcare, LLC | 2003 | — |
| −1 | K070929 | Acon U120 Urine Analyzer, Model U111-101 | ACON Laboratories, Inc. | 2007 | — |
| 0 (this device) | K111221 | Mission U500 Urine Analyzer | ACON Laboratories, Inc. | 2012 | — |
| +1 | K173327 | DIP/U.S. Urine Analysis Test System | Healthy.Io, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K070929 | Acon U120 Urine Analyzer, Model U111-101Summary page 2…e Device: ACON U120 Urine Analyzer, ACON Laboratories, Inc, marketed by ACON laboratories, Inc located at 10125 Mesa Rim Road, San Diego, CA 92121, USA. 5 10(k) Number: K070929 Description: The Missione U500 Urine Analyzer is a semi-automated reflectance photometer in conjunction with Mission Urinalysis… | 2007 |
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 |
|---|---|---|---|
| K173327 | DIP/U.S. Urine Analysis Test System | 2018 | 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 21 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K173327 (Healthy.Io, Ltd., 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K070929.
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 Mission® U500 Urine Analyzer is intended for use in conjunction with the Mission® Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection Nitrite. The instrument is intended for prescription, for in vitro diagnostic use only. Mission Urinalysis…
Read the full statement (108 words)
The Mission® U500 Urine Analyzer is intended for use in conjunction with the Mission® Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection Nitrite. The instrument is intended for prescription, for in vitro diagnostic use only. Mission Urinalysis Reagent Strips are available in different test configurations and the measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111221: Mission U500 Urine Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111221
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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