# K131795: Nanor and Efficast/Nanor Hybrid Thermoplastic Materials

- Pathway: 510(k) (Traditional)
- Applicant: Orfit Industries NV
- Decided: Sep 26, 2013 after 100 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

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

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K210894: Siddharth-II; Impact (2021), 1 descendant of its own
- K222762: Siddharth-II;Impact (2023), 0 descendants of its own

## Indications for use
The NANOR and NANOR/EFFICAST Hybrid Thermoplastic materials are used to retain and reproduce a patient's position during radiation therapy.

Source page: https://510kreport.com/device/K131795
Methodology: https://510kreport.com/methodology