510(k) · Cleared
ClearedSlendertone System Ultra Model E70/X70
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Medical Research, Ltd. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on May 5, 2010 as substantially equivalent to K070142 (Bio-Medical Research Corp., 2007) after a 90-day review. Its family tree reaches back 3 generations to 2001. 4 later devices descend from it.
- Decided
- May 5, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010335 (2001). 4 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 2 generations backK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
- 1 generation backK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
- This deviceK100320 Slendertone System Ultra Model E70/X70Bio-Medical Research, Ltd. · 2010
- Descendant · cites it directly · 1 of its ownK180688 SLENDERTONE CoreFit Abs 8, Type 734Bio-Medical Research, Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK151903 Slendertone connect AbsBio-Medical Research, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK203513 SLENDERTONE Evolve Abs, Type 735Bio-Medical Research, Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK161974 SLENDERTONE® Connect Abs, Type 570Bio-Medical Research, Ltd. · 2016
Most influential descendants
Showing 4 of 4 · See all- K180688SLENDERTONE CoreFit Abs 8, Type 734Bio-Medical Research, Ltd. · 2018 · cites it directly1descendant
- K151903Slendertone connect AbsBio-Medical Research, Ltd. · 2015 · cites it directly1descendant
- K203513SLENDERTONE Evolve Abs, Type 735Bio-Medical Research, Ltd. · 2021 · 2 generations on0descendants
- K161974SLENDERTONE® Connect Abs, Type 570Bio-Medical Research, Ltd. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| −2 | K022855 | Slendertone Flex Bottom & Thigh Toning System, Type 511 | Bio-Medical Research, Ltd. | 2003 | — |
| −1 | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts… | Bio-Medical Research Corp. | 2007 | — |
| 0 (this device) | K100320 | Slendertone System Ultra Model E70/X70 | Bio-Medical Research, Ltd. | 2010 | — |
| +1 | K180688 | SLENDERTONE CoreFit Abs 8, Type 734 | Bio-Medical Research, Ltd. | 2018 | — |
| +1 | K151903 | Slendertone connect Abs | Bio-Medical Research, Ltd. | 2015 | — |
| +2 | K203513 | SLENDERTONE Evolve Abs, Type 735 | Bio-Medical Research, Ltd. | 2021 | — |
| +2 | K161974 | SLENDERTONE® Connect Abs, Type 570 | Bio-Medical Research, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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 NGX? 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 NGX device
- #1 K250146 SofWave Systemscore 15.5 · 12 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 |
|---|---|---|---|
| * | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts, Models 390, E20Summary page 1…Slendertone System-Abs, Type 390 EIO/XIO device Manufacturer: Rio-Medical Research Ltd 5 1 0(k) Nos: K070 142 Directors; T. Kirwan (Chairman). Dr. P. A. Smith (Mana~inQY) P.K. McDonnell. C. M/inoizte. P3.… | 2007 |
What descends from it? (4)
2 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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K180688 (Bio-Medical Research, Ltd., 2018) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K070142.
How does its category compare?
All NGX devicesNGX Stimulator, Muscle, Powered, For Muscle Conditioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NGX
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGX
93in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGX
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NGX
15in 2025
MAUDE reports naming product code NGX, 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 | 7 | 135 | 0 | 0 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 4 | 132 | 0 | 0 |
| 2010 | 6 | 180 | 0 | 0 |
| 2011 | 5 | 291 | 0 | 1 |
| 2012 | 3 | 362 | 0 | 0 |
| 2013 | 6 | 269 | 2 | 1 |
| 2014 | 6 | 298 | 0 | 0 |
| 2015 | 9 | 184 | 0 | 7 |
| 2016 | 4 | 240 | 0 | 21 |
| 2017 | 10 | 108 | 0 | 2 |
| 2018 | 6 | 104 | 0 | 6 |
| 2019 | 14 | 167 | 0 | 4 |
| 2020 | 11 | 207 | 0 | 7 |
| 2021 | 12 | 256 | 0 | 5 |
| 2022 | 6 | 307 | 0 | 7 |
| 2023 | 12 | 96 | 0 | 8 |
| 2024 | 12 | 207 | 0 | 11 |
| 2025 | 15 | 93 | 0 | 15 |
| 2026 | 4 | 118 | 0 | — |
What is it indicated for?
The Slendertone System Ultra is indicated for the improvement of abdominal muscle tone,
for the strengthening of the abdominal muscles and for the development of a firmer
abdomen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100320: Slendertone System Ultra Model E70/X70.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100320
Report an extraction error
Are you the manufacturer?
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