510(k) · Cleared
ClearedFinn Chambers Aqua
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smartpractice · KXF Applicator, Absorbent Tipped, Non-Sterile
Cleared on Dec 19, 2012 after a 70-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 19, 2012
- Review
- 70 days
- Class
- Class I
- Product code
- KXF
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 KXF? 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?
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 KXF devicesKXF Applicator, Absorbent Tipped, Non-Sterile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KXF
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KXF
Too few KXF 510(k)s in any year since 2007 to give a median.
Recalls per year · KXF
No recall names KXF since 2007.
Adverse event reports per year · KXF
5in 2025
MAUDE reports naming product code KXF, 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 | 11 |
| 2008 | 0 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 15 |
| 2011 | 1 | — | 0 | 42 |
| 2012 | 1 | — | 0 | 37 |
| 2013 | 0 | — | 0 | 34 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 11 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 64 |
| 2021 | 0 | — | 0 | 134 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Finn Chambers AQUA is a patch test delivery system and holding device to place allergens and allergen mixes in contact with the surface of the skin during allergen patch tests. Finn Chambers AQUA patch test chambers are intended for use by, or under the supervision of, a physician for use as a patch test diagnostic device used in the testing of individuals suspected of having allergic or irritant contact dermatitis, photocontact dermatitis and experimental skin testing and allergy protocols.
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/K123184 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123184: Finn Chambers Aqua.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123184
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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