510(k) · Cleared
ClearedHRK-63-8 Knee Array Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mri Devices Corp. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Sep 25, 2003 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 25 later devices descend from it.
- Decided
- Sep 25, 2003
- Review
- 30 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 3 citing it directly.
- This deviceK032633 HRK-63-8 Knee Array CoilMri Devices Corp. · 2003
- Descendant · cites it directly · 21 of its ownK082636 TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3TQuality Electrodynamics · 2008 · Recalled
- Descendant · 2 generations on · 12 of its ownK100141 14-Channel Extremity Coil for Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2010
- Descendant · 3 generations on · 11 of its ownK130262 Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc. · 2013
- Descendant · 4 generations on · 9 of its ownK152283 MAGNETOM AmiraSiemens Medical Solutions USA, Inc. · 2015
- Descendant · 5 generations on · 7 of its ownK173600 MAGNETOM AmiraSiemens Medical Solutions USA, Inc. · 2017
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K082636TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3TQuality Electrodynamics · 2008 · cites it directly21descendants
- K10014114-Channel Extremity Coil for Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2010 · 2 generations on12descendants
- K130262Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc. · 2013 · 3 generations on11descendants
- K152283MAGNETOM AmiraSiemens Medical Solutions USA, Inc. · 2015 · 4 generations on9descendants
- K173600MAGNETOM AmiraSiemens Medical Solutions USA, Inc. · 2017 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032633 | HRK-63-8 Knee Array Coil | Mri Devices Corp. | 2003 | — |
| +1 | K082636 | TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T | Quality Electrodynamics | 2008 | 8 |
| +2 | K100141 | 14-Channel Extremity Coil for Magnetom Essenza | Siemens Medical Solutions USA, Inc. | 2010 | — |
| +3 | K130262 | Magnetom Essenza with Syngo MR D14 | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +4 | K152283 | MAGNETOM Amira | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +5 | K173600 | MAGNETOM Amira | Siemens Medical Solutions USA, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MOS? 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 MOS device
- #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (25)
See all 253 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K082636 (Quality Electrodynamics, 2008) has gone furthest, with 21 descendants of its own.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 2025
MAUDE reports naming product code MOS, 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 | 16 | 19 | 0 | 4 |
| 2008 | 19 | 33 | 2 | 2 |
| 2009 | 10 | 43 | 0 | 5 |
| 2010 | 16 | 78 | 1 | 13 |
| 2011 | 25 | 57 | 0 | 7 |
| 2012 | 15 | 49 | 1 | 12 |
| 2013 | 7 | 87 | 0 | 10 |
| 2014 | 12 | 60 | 0 | 4 |
| 2015 | 6 | 58 | 2 | 5 |
| 2016 | 11 | 42 | 0 | 7 |
| 2017 | 9 | 63 | 0 | 9 |
| 2018 | 10 | 30 | 0 | 7 |
| 2019 | 3 | 178 | 8 | 8 |
| 2020 | 5 | 51 | 1 | 2 |
| 2021 | 4 | 41 | 0 | 3 |
| 2022 | 11 | 79 | 0 | 5 |
| 2023 | 10 | 59 | 0 | 4 |
| 2024 | 10 | 39 | 13 | 8 |
| 2025 | 3 | 59 | 0 | 2 |
| 2026 | 10 | 45 | 0 | — |
What is it indicated for?
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic can be interpreted by a trained physician.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032633 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032633: HRK-63-8 Knee Array Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032633
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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