510(k) · Cleared
ClearedFutura
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dr. Oliver Wenker, M.D., M.B.A. · IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Cleared on Nov 3, 2011 as substantially equivalent to K926410 (Bowater Research, Inc., 1993) and 1 other predicate after a 427-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Nov 3, 2011
- Review
- 427 days
- Class
- Class II
- Product code
- IMG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K926410 (1993). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K233099GladiatorRohrer Aesthetics, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926410 | Ultratone 8+ & 20 | Bowater Research, Inc. | 1993 | — |
| 0 (this device) | K102524 | Futura | Dr. Oliver Wenker, M.D., M.B.A. | 2011 | — |
| +1 | K233099 | Gladiator | Rohrer Aesthetics, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 IMG? 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 IMG device
- #1 K244041 Ultrasound Therapy Workstation (XMS-UET2)score 10.7 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K926410 | Ultratone 8+ & 20Summary page 1…evices Predicate Devices: Manufacturer, Device, Approval No.: Ultratone Scientific Instruments Ltd, Ultratone 20, K92641 0 Hwang Sun Enterprise Co. Ltd, Ultrasonic Therapy Appliance, K05041 0 Io… | 1993 |
| * | K050410 | Hes Ultrasonic Therapy Appliance, Models HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)Summary page 1…Approval No.: Ultratone Scientific Instruments Ltd, Ultratone 20, K92641 0 Hwang Sun Enterprise Co. Ltd, Ultrasonic Therapy Appliance, K05041 0 Io 1Z91S72Z{ Device Description The Future Pro (US Specificati… | 2005 |
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 |
|---|---|---|---|
| K233099 | Gladiator | 2024 | 0 |
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?
How does its category compare?
All IMG devicesIMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · IMG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IMG
226in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IMG
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMG
9in 2025
MAUDE reports naming product code IMG, 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 | 3 | 110 | 0 | 0 |
| 2008 | 0 | — | 2 | 37 |
| 2009 | 0 | — | 0 | 26 |
| 2010 | 1 | — | 0 | 6 |
| 2011 | 3 | 226 | 0 | 21 |
| 2012 | 2 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 4 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 0 | — | 0 | 10 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 1 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
MUSCLE STIMULATOR
INDICATIONS FOR USE:
1. Relaxation of muscle spasms
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Muscle re-education
5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
6. Maintaining or increasing range of motion
Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
ULTRASOUND
INDICATIONS FOR USE:
Application of deep heat for:
1. Temporary relief of minor pain
2. Muscle spasm relief
3. Joint contracture relief
Not for treatment of malignancies. Not for use on the face.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102524: Futura.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102524
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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