# K010852: Osmed Tissue Expander

- Pathway: 510(k) (Traditional)
- Applicant: Iop, Inc.
- Decided: Aug 13, 2001 after 145 days
- Product code: NFM (Expander, Tissue, Orbital)
- Device class: 2
- Regulation: 21 CFR 886.3320
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K060151: Orbital Tissue Expander (Ote) (2006), 2 descendants of its own
- K070130: Orbital Reconstructive Implant (2007), 1 descendant of its own
- K083342: Orbital Reconstructive Implant II (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K010852
Methodology: https://510kreport.com/methodology