# K123184: Finn Chambers Aqua

- Pathway: 510(k) (Traditional)
- Applicant: Smartpractice
- Decided: Dec 19, 2012 after 70 days
- Product code: KXF (Applicator, Absorbent Tipped, Non-Sterile)
- Device class: 1
- Regulation: 21 CFR 880.6025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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.

Source page: https://510kreport.com/device/K123184
Methodology: https://510kreport.com/methodology