510(k) · Cleared
Recalled · Class II · 2019TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quality Electrodynamics · MOS Coil, Magnetic Resonance, Specialty
Cleared on Sep 25, 2008 as substantially equivalent to K032633 (Mri Devices Corp., 2003) and 2 other predicates after a 15-day review. Its family tree reaches back 4 generations to 1989. 21 later devices descend from it. It has been recalled 8 times.
- Decided
- Sep 25, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- MOS
- Recalls
- 8
- Predicates
- 3
Its longest line of descent runs back 4 generations to K893619 (1989). 15 ancestors in all. 21 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK893619 Vista MR 2055 HP SystemPhilips Medical Systems (Cleveland), Inc. · 1989
- 3 generations backK960497 Flexible Phased Array Spine CoilPhilips Medical Systems (Cleveland), Inc. · 1996
- 2 generations backK971246 Leo 7000 Quadrature Knee CoilUsa Instruments, Inc. · 1997
- 1 generation backK023982 Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist…Usa Instruments, Inc. · 2003
- This deviceK082636 TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3TQuality Electrodynamics · 2008
- Descendant · cites it directly · 12 of its ownK100141 14-Channel Extremity Coil for Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2010
- Descendant · 2 generations on · 11 of its ownK130262 Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc. · 2013
- Descendant · 3 generations on · 9 of its ownK152283 MAGNETOM AmiraSiemens Medical Solutions USA, Inc. · 2015
- Descendant · 4 generations on · 7 of its ownK173600 MAGNETOM AmiraSiemens Medical Solutions USA, Inc. · 2017
- Descendant · 4 generations on · 7 of its ownK163211 MAGNETOM Sempra with syngo MR E11SSiemens Medical Solutions USA, Inc. · 2017
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K10014114-Channel Extremity Coil for Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2010 · cites it directly12descendants
- K130262Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc. · 2013 · 2 generations on11descendants
- K152283MAGNETOM AmiraSiemens Medical Solutions USA, Inc. · 2015 · 3 generations on9descendants
- K173600MAGNETOM AmiraSiemens Medical Solutions USA, Inc. · 2017 · 4 generations on7descendants
- K163211MAGNETOM Sempra with syngo MR E11SSiemens Medical Solutions USA, Inc. · 2017 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K893619 | Vista MR 2055 HP System | Philips Medical Systems (Cleveland), Inc. | 1989 | — |
| −3 | K960497 | Flexible Phased Array Spine Coil | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −2 | K971246 | Leo 7000 Quadrature Knee Coil | Usa Instruments, Inc. | 1997 | — |
| −1 | K023982 | Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist Coil | Usa Instruments, Inc. | 2003 | — |
| 0 (this device) | K082636 | TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T | Quality Electrodynamics | 2008 | — |
| +1 | K100141 | 14-Channel Extremity Coil for Magnetom Essenza | Siemens Medical Solutions USA, Inc. | 2010 | — |
| +2 | K130262 | Magnetom Essenza with Syngo MR D14 | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +3 | K152283 | MAGNETOM Amira | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +4 | K173600 | MAGNETOM Amira | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +4 | K163211 | MAGNETOM Sempra with syngo MR E11S | Siemens Medical Solutions USA, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 2 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K032633 | HRK-63-8 Knee Array CoilSummary page 2…510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 10.Comparison with Predicate Devices 510(k) # Device Manufacturer K032633 HRK-63 Knee Array Coil MRI Devices K050299 HRK-123 Knee Array Coil MRI Devi… | 2003 |
| * | K050299 | HRK-123 Knee Array CoilSummary page 2…Predicate Devices 510(k) # Device Manufacturer K032633 HRK-63 Knee Array Coil MRI Devices K050299 HRK-123 Knee Array Coil MRI Devices K023982 Leo III Tx/Rx Quadrature Knee Coil USA Inst… | 2005 |
| * | K023982 | Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist CoilSummary page 2…Manufacturer K032633 HRK-63 Knee Array Coil MRI Devices K050299 HRK-123 Knee Array Coil MRI Devices K023982 Leo III Tx/Rx Quadrature Knee Coil USA Instruments The 1.5T and 3T Siemens knee coils and predicate devices are desi… | 2003 |
What descends from it? (21)
See all 214 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 20, 2019 | Class II | Z-0031-2020 | Nonconforming Material/Component | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. |
| Aug 20, 2019 | Class II | Z-0037-2020 | Nonconforming Material/Component | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. |
| Aug 20, 2019 | Class II | Z-0033-2020 | Nonconforming Material/Component | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. |
| Aug 20, 2019 | Class II | Z-0036-2020 | Nonconforming Material/Component | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. |
| Aug 20, 2019 | Class II | Z-0032-2020 | Nonconforming Material/Component | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. |
| Aug 20, 2019 | Class II | Z-0034-2020 | Nonconforming Material/Component | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. |
| Aug 20, 2019 | Class II | Z-0035-2020 | Nonconforming Material/Component | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. |
| Jul 27, 2012 | Class II | Z-2314-2012 | Error in labeling | On July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not functional because the coil identification code for the device was incorrect. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K100141 (Siemens Medical Solutions USA, Inc., 2010) has gone furthest, with 12 descendants of its own.
- 2 other devices also cite its predicate K032633.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
For use with a 1.5T Siemens Avanto/Espree or 3T Siemens TrioNerio magnetic resonance scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082636 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082636: TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082636
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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