510(k) · Cleared
ClearedASI Automated ASI RPR Test for Syphilis on the ASI Evolution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arlington Scientific, Inc. (Asi) · GMQ Antigens, Nontreponemal, All
Cleared on Nov 30, 2018 after an 87-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Nov 30, 2018
- Review
- 87 days
- Class
- Class II
- Product code
- GMQ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK182391 ASI Automated ASI RPR Test for Syphilis on the ASI EvolutionArlington Scientific, Inc. (Asi) · 2018
- Descendant · cites it directly · 0 of its ownK201438 ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use…Arlington Scientific, Inc. (Asi) · 2020
Most influential descendants
Showing 1 of 1 · See all- K201438ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution…Arlington Scientific, Inc. (Asi) · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K182391 | ASI Automated ASI RPR Test for Syphilis on the ASI Evolution | Arlington Scientific, Inc. (Asi) | 2018 | — |
| +1 | K201438 | ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI… | Arlington Scientific, Inc. (Asi) | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 GMQ? 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 GMQ device
- #1 K250249 Gold Standard Diagnostics (GSD) AIX1000 Rapid…score 10.8 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201438 | ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution… | 2020 | 0 |
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, K201438 (Arlington Scientific, Inc. (Asi), 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GMQ devicesGMQ Antigens, Nontreponemal, All: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · GMQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GMQ
Too few GMQ 510(k)s in any year since 2007 to give a median.
Recalls per year · GMQ
No recall names GMQ since 2007.
Adverse event reports per year · GMQ
2in 2024
MAUDE reports naming product code GMQ, 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 | 3 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K182391 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182391: ASI Automated ASI RPR Test for Syphilis on the ASI Evolution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182391
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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