510(k) · Cleared
ClearedKenlor Liquid Urine Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kenlor Industries, Inc. · JJW Urinalysis Controls (Assayed And Unassayed)
Cleared on Mar 9, 1989 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Mar 9, 1989
- Review
- 31 days
- Class
- Class I
- Product code
- JJW
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK890577 Kenlor Liquid Urine ControlKenlor Industries, Inc. · 1989
- Descendant · cites it directly · 10 of its ownK965171 Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426)Bio-Rad · 1997
- Descendant · 2 generations on · 9 of its ownK031231 Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek…Bio-Rad · 2003
- Descendant · 3 generations on · 6 of its ownK070848 Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level…Bio-Rad, Diagnostics Grp. · 2007
- Descendant · 4 generations on · 3 of its ownK142391 Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips…ACON Laboratories, Inc. · 2014
- Descendant · 5 generations on · 1 of its ownK182384 ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd. · 2019
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K965171Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426)Bio-Rad · 1997 · cites it directly10descendants
- K031231Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control Level 2…Bio-Rad · 2003 · 2 generations on9descendants
- K070848Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level 2,Minipak, 435,436,437,435XBio-Rad, Diagnostics Grp. · 2007 · 3 generations on6descendants
- K142391Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (…ACON Laboratories, Inc. · 2014 · 4 generations on3descendants
- K182384ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd. · 2019 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K890577 | Kenlor Liquid Urine Control | Kenlor Industries, Inc. | 1989 | — |
| +1 | K965171 | Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426) | Bio-Rad | 1997 | — |
| +2 | K031231 | Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control… | Bio-Rad | 2003 | — |
| +3 | K070848 | Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level 2,Minipak… | Bio-Rad, Diagnostics Grp. | 2007 | — |
| +4 | K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (… | ACON Laboratories, Inc. | 2014 | — |
| +5 | K182384 | ACR LAB Urine Analysis Test System | Healthy.Io, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJW? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 122 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?
- Of its descendants, K965171 (Bio-Rad, 1997) has gone furthest, with 10 descendants of its own.
How does its category compare?
All JJW devicesJJW Urinalysis Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJW
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJW
Too few JJW 510(k)s in any year since 2007 to give a median.
Recalls per year · JJW
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJW
1in 2022
MAUDE reports naming product code JJW, 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 | 2 | — | 1 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 7 | 1 |
| 2013 | 0 | — | 1 | 24 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 2 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K890577 · printed Nov 4, 2026
Cite this page
510(k) Report. “K890577: Kenlor Liquid Urine Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K890577
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026