# K955368: Duralastic I

- Pathway: 510(k) (Traditional)
- Applicant: Allied Biomedical Corp.
- Decided: Feb 8, 1996 after 78 days
- Product code: MIB (Elastomer, Silicone Block)
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 1 cites it directly.
0 of 16 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
- K972317: Montgomery Thyroplasty Implant System (1997), 14 descendants of its own
- K982294: Xomed Silicone Pre-Form Blocks (1998), 12 descendants of its own
- K013243: Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1 (2002), 11 descendants of its own
- K033398: Laryngeal Augmentation Implant (2003), 10 descendants of its own
- K060815: Juliesse Injectable Laryngeal Augmentation Implant (2006), 6 descendants of its own

Source page: https://510kreport.com/device/K955368
Methodology: https://510kreport.com/methodology