510(k) · Cleared
ClearedAimstick Urine Reagent Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Germaine Laboratories, Inc. · CEN Dye-Indicator, Ph (Urinary, Non-Quantitative)
Cleared on Oct 26, 2005 after a 120-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 26, 2005
- Review
- 120 days
- Class
- Class I
- Product code
- CEN
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 CEN? 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 |
|---|---|---|---|
| * | — | Bayer MultiStix® 10 SG Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All CEN devicesCEN Dye-Indicator, Ph (Urinary, Non-Quantitative): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEN
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · CEN
Too few CEN 510(k)s in any year since 2007 to give a median.
Recalls per year · CEN
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEN
1in 2018
MAUDE reports naming product code CEN, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 2 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The AimStick® Urine Reagent Strips are intended for the qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, and Leukocytes in urine for persons to test by visual comparison with a color chart on the bottle label. This product is for professional use. Test results may provide information regarding the status of carbohydrate metabolism, kidney function, liver function, acid-base balance, and bacturia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051727 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051727: Aimstick Urine Reagent Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051727
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026