510(k) · Cleared
ClearedChemstrip (R) 10 with SG Urine Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Cleared on Jan 11, 1990 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jan 11, 1990
- Review
- 63 days
- Class
- Class II
- Product code
- JIL
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK896454 Chemstrip (R) 10 with SG Urine Test StripsBoehringer Mannheim Corp. · 1990
- Descendant · cites it directly · 3 of its ownK040703 Uristik H Series Reagent Strips for UrinalysisDirui Industrial Co., Ltd. · 2004
- Descendant · cites it directly · 2 of its ownK990206 Serim Blood Leak Test StripSerim Research Corp. · 1999
- Descendant · 2 generations on · 1 of its ownK082811 Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and…Urit Medical Electronic Co., Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK012115 Serim Blood Leak Test Strip-2Serim Research Corp. · 2001
- Descendant · 3 generations on · 0 of its ownK232317 UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips…Urit Medical Electronic Co., Ltd. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K040703Uristik H Series Reagent Strips for UrinalysisDirui Industrial Co., Ltd. · 2004 · cites it directly3descendants
- K990206Serim Blood Leak Test StripSerim Research Corp. · 1999 · cites it directly2descendants
- K082811Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine AnalyzersUrit Medical Electronic Co., Ltd. · 2009 · 2 generations on1descendant
- K012115Serim Blood Leak Test Strip-2Serim Research Corp. · 2001 · cites it directly1descendant
- K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine…Urit Medical Electronic Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K896454 | Chemstrip (R) 10 with SG Urine Test Strips | Boehringer Mannheim Corp. | 1990 | — |
| +1 | K040703 | Uristik H Series Reagent Strips for Urinalysis | Dirui Industrial Co., Ltd. | 2004 | — |
| +1 | K990206 | Serim Blood Leak Test Strip | Serim Research Corp. | 1999 | — |
| +2 | K082811 | Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine… | Urit Medical Electronic Co., Ltd. | 2009 | — |
| +1 | K012115 | Serim Blood Leak Test Strip-2 | Serim Research Corp. | 2001 | — |
| +3 | K232317 | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA… | Urit Medical Electronic Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2024 | 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 JIL? 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 JIL device
- #1 K193514 AUTION MAX AX-4060 Urinalysis Systemscore 6.1 · 4 generations · no Class I recall
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? (7)
3 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, K040703 (Dirui Industrial Co., Ltd., 2004) has gone furthest, with 3 descendants of its own.
How does its category compare?
All JIL devicesJIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIL
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JIL
187in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIL
15in 2025
MAUDE reports naming product code JIL, 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 | 3 | 284 | 0 | 20 |
| 2008 | 0 | — | 0 | 20 |
| 2009 | 1 | — | 0 | 16 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 1 | — | 0 | 14 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 32 |
| 2014 | 1 | — | 4 | 47 |
| 2015 | 1 | — | 0 | 45 |
| 2016 | 2 | — | 1 | 40 |
| 2017 | 1 | — | 0 | 33 |
| 2018 | 4 | 187 | 0 | 68 |
| 2019 | 1 | — | 0 | 67 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 1 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 0 | — | 1 | 15 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K896454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K896454: Chemstrip (R) 10 with SG Urine Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K896454
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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