510(k) · Cleared
ClearedTriage Statmeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosite Incorporated · KHO Fluorometer, For Clinical Use
Cleared on Jan 13, 1998 after a 117-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 29 later devices descend from it.
- Decided
- Jan 13, 1998
- Review
- 117 days
- Class
- Class I
- Product code
- KHO
- Recalls
- None
- Predicates
- 0
29 later devices descend from it, 4 citing it directly.
- This deviceK973547 Triage StatmeterBiosite Incorporated · 1998
- Descendant · cites it directly · 17 of its ownK220046 Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence…Shenzhen Superbio Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 11 of its ownK231698 AllTest Fentanyl Rapid Test (Urine)Hangzhou AllTest Biotech Co., Ltd. · 2023
- Descendant · 3 generations on · 9 of its ownK233417 AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd. · 2023
- Descendant · cites it directly · 9 of its ownK080635 MedtoxscanMedtox Diagnostics, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 4 of its ownK091454 Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc. · 2009
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K220046Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11Shenzhen Superbio Technology Co., Ltd. · 2022 · cites it directly17descendants
- K231698AllTest Fentanyl Rapid Test (Urine)Hangzhou AllTest Biotech Co., Ltd. · 2023 · 2 generations on11descendants
- K233417AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd. · 2023 · 3 generations on9descendants
- K080635MedtoxscanMedtox Diagnostics, Inc. · 2009 · cites it directly9descendants
- K091454Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc. · 2009 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973547 | Triage Statmeter | Biosite Incorporated | 1998 | — |
| +1 | K220046 | Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer… | Shenzhen Superbio Technology Co., Ltd. | 2022 | — |
| +2 | K231698 | AllTest Fentanyl Rapid Test (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2023 | — |
| +3 | K233417 | AllTest Fentanyl Urine Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | 2023 | — |
| +1 | K080635 | Medtoxscan | Medtox Diagnostics, Inc. | 2009 | 1 |
| +2 | K091454 | Profile-V Medtoxscan Drugs of Abuse Test System | Medtox Diagnostics, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 13 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KHO? 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (29)
See all 294 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, K220046 (Shenzhen Superbio Technology Co., Ltd., 2022) has gone furthest, with 17 descendants of its own.
How does its category compare?
All KHO devicesKHO Fluorometer, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHO
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KHO
Too few KHO 510(k)s in any year since 2007 to give a median.
Recalls per year · KHO
7in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHO
178in 2025
MAUDE reports naming product code KHO, 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 | 5 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 24 |
| 2010 | 0 | — | 0 | 49 |
| 2011 | 0 | — | 2 | 29 |
| 2012 | 1 | — | 1 | 68 |
| 2013 | 0 | — | 0 | 53 |
| 2014 | 0 | — | 2 | 65 |
| 2015 | 0 | — | 0 | 30 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 0 | — | 4 | 152 |
| 2018 | 0 | — | 7 | 2,123 |
| 2019 | 0 | — | 0 | 440 |
| 2020 | 0 | — | 0 | 257 |
| 2021 | 0 | — | 0 | 213 |
| 2022 | 0 | — | 0 | 224 |
| 2023 | 0 | — | 0 | 260 |
| 2024 | 0 | — | 0 | 168 |
| 2025 | 0 | — | 0 | 178 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
fluometer for the measurement of fluorescence in various assay systems. General fluorometer.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973547: Triage Statmeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973547
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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