510(k) · Cleared
ClearedTxRx Knee 15 Flare MR Coil 1.5T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quality Electrodynamics, LLC · MOS Coil, Magnetic Resonance, Specialty
Cleared on Nov 30, 2016 as substantially equivalent to K082636 (Quality Electrodynamics, 2008) after a 37-day review. Its family tree reaches back 5 generations to 1989.
- Decided
- Nov 30, 2016
- Review
- 37 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K893619 (1989). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK893619 Vista MR 2055 HP SystemPhilips Medical Systems (Cleveland), Inc. · 1989
- 4 generations backK960497 Flexible Phased Array Spine CoilPhilips Medical Systems (Cleveland), Inc. · 1996
- 3 generations backK971246 Leo 7000 Quadrature Knee CoilUsa Instruments, Inc. · 1997
- 2 generations backK023982 Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist…Usa Instruments, Inc. · 2003
- 1 generation backK082636 TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3TQuality Electrodynamics · 2008 · Recalled
- This deviceK162966 TxRx Knee 15 Flare MR Coil 1.5TQuality Electrodynamics, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K893619 | Vista MR 2055 HP System | Philips Medical Systems (Cleveland), Inc. | 1989 | — |
| −4 | K960497 | Flexible Phased Array Spine Coil | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −3 | K971246 | Leo 7000 Quadrature Knee Coil | Usa Instruments, Inc. | 1997 | — |
| −2 | K023982 | Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist Coil | Usa Instruments, Inc. | 2003 | — |
| −1 | K082636 | TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T | Quality Electrodynamics | 2008 | 8 |
| 0 (this device) | K162966 | TxRx Knee 15 Flare MR Coil 1.5T | Quality Electrodynamics, LLC | 2016 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K082636 | TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3TSummary page 4…sonance diagnostic device (21 CFR 892.1000, Product Code MOS, Class II) 8. Unmodified Device 1.5T TxRx 15Ch Knee Coil, Quality Electrodynamics, LLC., K082636 9. Device Description The TxRx Knee 15 Flare MR Coil 1.5T is a transmit/receive, 15-channel phased array coil… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 16 ancestors have a recall of any class.
- 3 other devices also cite its predicate K082636.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The TxRx Knee 15 Flare MR Coil 1.5T is intended for use with Siemens 1.5T MR systems 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/K162966 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162966: TxRx Knee 15 Flare MR Coil 1.5T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162966
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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