510(k) · Cleared
ClearedHTS Extremity Coil, HTS Surface Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Time Medical Systems, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Sep 30, 2011 as substantially equivalent to K092230 (Time Medical Limited, 2009) and 1 other predicate after a 51-day review. Its family tree reaches back 2 generations to 2008.
- Decided
- Sep 30, 2011
- Review
- 51 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K073457 (2008). 3 ancestors in all, the oldest K022863 (2003). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K073457 | Mstar MPD4500 | Xinaomdt Technology Co., Ltd. | 2008 | — |
| −1 | K092230 | Mona - Orthopedic Mri System, Model TMS-200ORTH-01 | Time Medical Limited | 2009 | — |
| 0 (this device) | K112293 | HTS Extremity Coil, HTS Surface Coil | Time Medical Systems, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (2)
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 |
|---|---|---|---|
| * | K092230 | Mona - Orthopedic Mri System, Model TMS-200ORTH-01Summary page 1…ivalence.................................................................. 2 2.1 SUMMARY 510(k) Number TRO K092230 K022863 (Mona… | 2009 |
| * | K022863 | HTS CoilSummary page 1…....................................................... 2 2.1 SUMMARY 510(k) Number TRO K092230 K022863 (Mona… | 2003 |
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 3 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
HTS Surface Coil is used to image peripheral anatomies, such as, wrist, ankle, Temporo-mandibular Joints (TMJ), Eye, finger and other parts of the body, close to the surface of skin. It is compatible to be used with Time Medical's 0.35T PICA Whole Body MRI System.
HTS Extremity Coil is predominantly used for imaging anatomies, such as, knee, ankle, and wrist. It is compatible to be used with Time Medical's 0.35T PICA Whole Body MRI System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112293 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112293: HTS Extremity Coil, HTS Surface Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112293
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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