# K142228: Heated Eye Pad

- Pathway: 510(k) (Traditional)
- Applicant: Digital Heat Corporation
- Decided: Feb 9, 2015 after 180 days
- Product code: IRT (Pad, Heating, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5740
- 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
The Heated Eye Pad ophthalmic warmer is a powered heating pad for the application of localized heat therapy. Use for treatment when the current medical community recommends the application of a warm compress to the eyelids. Such applications would include Meibomian Gland Dysfunction (MGD), Dry Eye, Blepharitis, Stye, or Chalazia.

Source page: https://510kreport.com/device/K142228
Methodology: https://510kreport.com/methodology