# K920354: Ophthalmic Sponges

- Pathway: 510(k) (Traditional)
- Applicant: Ultracell Medical Technologies, Inc.
- Decided: Aug 5, 1992 after 191 days
- Product code: HOZ (Sponge, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4790
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K130117: Network Eye Spears, Points, Drains, Wicks and Shields (2013), 0 descendants of its own

## Recalls of this device
- Dec 20, 2022 · Class II · Z-1199-2023: Device packaging may contain open seals, compromising product sterility.

Source page: https://510kreport.com/device/K920354
Methodology: https://510kreport.com/methodology