# K010850: Polestar N-10

- Pathway: 510(k) (Traditional)
- Applicant: Odin Medical Technologies, Ltd.
- Decided: Dec 17, 2001 after 271 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (1 Class I)
- 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.
1 of 3 devices in its family (counting itself) has 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
- K032541: Polestar N-20 (2003), 1 descendant of its own
- K092308: Polestar, Model N-30 (2010), 0 descendants of its own

## Recalls of this device
- Oct 17, 2013 · Class I · Z-0352-2014: Spacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in CAS I/II Absorbers may fail due to loose fastening hardware i

Source page: https://510kreport.com/device/K010850
Methodology: https://510kreport.com/methodology