# K780987: Soft Silicone Elastomer Sponge Explant

- Pathway: 510(k) (Traditional)
- Applicant: Medical Instrument Research Assoc., Inc.
- Decided: Sep 28, 1978 after 106 days
- Product code: HOZ (Sponge, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4790
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K950806: Solid Dilicone Implants, Sdilicone Sponge Implants (1996), 2 descendants of its own
- K083342: Orbital Reconstructive Implant II (2009), 0 descendants of its own
- K023481: Microvision Scleral Buckling Components (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K780987
Methodology: https://510kreport.com/methodology