# K984345: Aromapatch

- Pathway: 510(k) (Traditional)
- Applicant: Envis, Inc.
- Decided: Mar 19, 1999 after 105 days
- Product code: LRD (Applicator, Ent Drug)
- Device class: 1
- Regulation: 21 CFR 874.5220
- 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
Aromapatch™ nasal inhaler shall be single use only and are to be used by the general public as a medium for aroma inhalation of essential oils, such as eucalyptus oil.

Source page: https://510kreport.com/device/K984345
Methodology: https://510kreport.com/methodology