510(k) · Cleared
ClearedAcon U120 Urine Analyzer, Model U111-101
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · KQO Automated Urinalysis System
Cleared on Jul 30, 2007 as substantially equivalent to K031947 (Bayer Healthcare, LLC, 2003) after a 118-day review. Its family tree reaches back 2 generations to 1991. 3 later devices descend from it.
- Decided
- Jul 30, 2007
- Review
- 118 days
- Class
- Class I
- Product code
- KQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K905396 (1991). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK905396 Hemastix Reagent StripsHeraeus Kulzer, Inc. · 1991
- 1 generation backK031947 Bayer Clinitek Status AnalyzerBayer Healthcare, LLC · 2003
- This deviceK070929 Acon U120 Urine Analyzer, Model U111-101ACON Laboratories, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK111221 Mission U500 Urine AnalyzerACON Laboratories, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK173327 DIP/U.S. Urine Analysis Test SystemHealthy.Io, Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK142543 Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls…ACON Laboratories, Inc. · 2015
Most influential descendants
Showing 3 of 3 · See all- K111221Mission U500 Urine AnalyzerACON Laboratories, Inc. · 2012 · cites it directly1descendant
- K173327DIP/U.S. Urine Analysis Test SystemHealthy.Io, Ltd. · 2018 · 2 generations on0descendants
- K142543Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube…ACON Laboratories, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905396 | Hemastix Reagent Strips | Heraeus Kulzer, Inc. | 1991 | — |
| −1 | K031947 | Bayer Clinitek Status Analyzer | Bayer Healthcare, LLC | 2003 | — |
| 0 (this device) | K070929 | Acon U120 Urine Analyzer, Model U111-101 | ACON Laboratories, Inc. | 2007 | — |
| +1 | K111221 | Mission U500 Urine Analyzer | ACON Laboratories, Inc. | 2012 | — |
| +2 | K173327 | DIP/U.S. Urine Analysis Test System | Healthy.Io, Ltd. | 2018 | — |
| +1 | K142543 | Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission… | ACON Laboratories, Inc. | 2015 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 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 KQO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K031947 | Bayer Clinitek Status AnalyzerSummary page 2…cate Device: Bayer Clinitek Status Urine Chemistry Analyzer Bayer Healthcare, LLC, marketed by Bayer Healthcare, LLC, located at Medfield, MA 02052, USA. 510(k) Number: K031947 Description: The U120 Urine Analyzer is a reflectance photometer that analyzes the intensity and color of light reflected from… | 2003 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 3 companies; a new generation was cleared every 12.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K111221 (ACON Laboratories, Inc., 2012) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K031947.
How does its category compare?
All KQO devicesKQO Automated Urinalysis System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · KQO
2in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KQO
Too few KQO 510(k)s in any year since 2007 to give a median.
Recalls per year · KQO
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KQO
12in 2025
MAUDE reports naming product code KQO, 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 | 4 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 2 | — | 7 | 3 |
| 2011 | 2 | — | 2 | 8 |
| 2012 | 0 | — | 0 | 15 |
| 2013 | 1 | — | 1 | 92 |
| 2014 | 1 | — | 0 | 106 |
| 2015 | 2 | — | 0 | 238 |
| 2016 | 0 | — | 1 | 373 |
| 2017 | 0 | — | 0 | 20 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 0 | — | 2 | 64 |
| 2020 | 0 | — | 0 | 21 |
| 2021 | 0 | — | 1 | 13 |
| 2022 | 0 | — | 0 | 15 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The ACON TM U120 Urine Analyzer is intended for use in conjunction with the ACON Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic Acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection of Nitrite. The ACON Urinalysis Reagent Strips are available in different combinations of the aforementioned…
Read the full statement (112 words)
The ACON TM U120 Urine Analyzer is intended for use in conjunction with the ACON Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic Acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection of Nitrite. The ACON Urinalysis Reagent Strips are available in different combinations of the aforementioned analytes. The instrument is intended for professional, in vitro diagnostic use only. 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/K070929 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070929: Acon U120 Urine Analyzer, Model U111-101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070929
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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