# K021843: Eyefeel Ophthalmic Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Lipid, Inc.
- Decided: Sep 3, 2002 after 90 days
- Product code: IMD (Pack, Hot Or Cold, Disposable)
- Device class: 1
- Regulation: 21 CFR 890.5710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970399 (1997). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982652: Allegiance Porta-Warm Mattress, Allegiance Healthcare Corp. (1999) Summary page 1.
- K973770: Allegiance Kwik Heat Warm Perineal Pack, Allegiance Healthcare Corp. (1997) Summary page 1.

## Most influential descendants
- K082087: Eyefeel Ophthalmic Warmer (2008), 0 descendants of its own

## Indications for use
The EyeFeelTM Ophthalmic warmer is a hot disposable pack for the application of localized heat therapy in cases of chronic inflammatory and cystic conditions of the eye lids, including rneibornian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.

Source page: https://510kreport.com/device/K021843
Methodology: https://510kreport.com/methodology