# K850785: Fastube Nerve Regeneration Device

- Pathway: 510(k) (Traditional)
- Applicant: Research Medical, Inc.
- Decided: Jul 10, 1985 after 134 days
- Product code: JXI (Cuff, Nerve)
- Device class: 2
- Regulation: 21 CFR 882.5275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
38 later devices descend from it; 2 cite it directly.
0 of 39 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
- K012814: Collagen Nerve Cuff (2001), 37 descendants of its own
- K060952: Collagen Nerve Wrap (2006), 22 descendants of its own
- K080452: Collagen Tendon Wrap (2008), 15 descendants of its own
- K112423: Collagen Tendon Sheet (2011), 14 descendants of its own
- K031069: Surgisis Nerve Cuff (2003), 10 descendants of its own

Source page: https://510kreport.com/device/K850785
Methodology: https://510kreport.com/methodology