510(k) · Cleared
Recalled · Class II · 2016Polestar N-20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Odin Medical Technologies, Ltd. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Sep 12, 2003 as substantially equivalent to K010850 (Odin Medical Technologies, Ltd., 2001) after a 25-day review. Its family tree reaches back 1 generation to 2001. 1 of the 3 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Sep 12, 2003
- Review
- 25 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010850 (2001). 1 later device descends from it, 1 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK010850 Polestar N-10Odin Medical Technologies, Ltd. · 2001 · Recalled (Class I)
- This deviceK032541 Polestar N-20Odin Medical Technologies, Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK092308 Polestar, Model N-30Medtronic Navigation Israel, Ltd. · 2010 · Recalled
Class I recalls in this family
- K010850 Polestar N-10direct predicate · 2001
Most influential descendants
Showing 1 of 1 · See all- K092308Polestar, Model N-30Medtronic Navigation Israel, Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010850 | Polestar N-10 | Odin Medical Technologies, Ltd. | 2001 | Class I |
| 0 (this device) | K032541 | Polestar N-20 | Odin Medical Technologies, Ltd. | 2003 | — |
| +1 | K092308 | Polestar, Model N-30 | Medtronic Navigation Israel, Ltd. | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010850 | Polestar N-10Summary page 4…807.92(a)(6) - Substantial Equivalence Comparison Table: Odin Odin Polestar N-10 (K010850) Polestar N-20 Clinical application Extremities and selected Extremities and selected… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092308 | Polestar, Model N-30 | 2010 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 20, 2016 | Class II | Z-2129-2016 | Process change control | Medtronic Navigation is recalling certain components of the PoleStar system (N20 / N30) because of misplaced ground pins which may cause electrical shock to the user. |
| Jul 1, 2010 | Not classified | Z-2240-2010 | Device Design | Electronic box on headstrap may overheat, causing burn to patient. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K010850Polestar N-10Odin Medical Technologies, Ltd. · 2001 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has a recall, Class I.
- Of its descendants, K092308 (Medtronic Navigation Israel, Ltd., 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
The Polestar N-20 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of the extremities and selected sections of the head. The images produced by the Polestar N-20 reflect the spatial distribution of protons (Hydrogen Nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (Tl), spin-spin relaxation…
Read the full statement (123 words)
The Polestar N-20 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of the extremities and selected sections of the head. The images produced by the Polestar N-20 reflect the spatial distribution of protons (Hydrogen Nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (Tl), spin-spin relaxation time (T2) and T2*.
Anatomical regions: extremities and selected sections of the head.
Nuclei excited: H- 1
Diagnostic uses: T1, T2, T2* and density weighted imaging.
The Polestar N-20 is intended to be used intraoperatively in a standard operating room. When interpreted by trained physicians, the MR images provide information that can be useful in determining a diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032541 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032541: Polestar N-20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032541
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026