510(k) Report

510(k) · Cleared

Cleared

Slendertone Flex, Model, 512

K010335510(k) TraditionalCleared Sep 27, 2001237-day reviewClass II21 CFR 890.5850

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bio-Medical Research, Ltd. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning

Cleared on Sep 27, 2001 after a 237-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 73 later devices descend from it.

Decided
Sep 27, 2001
Review
237 days
Class
Class II
Product code
NGX
Recalls
None
Predicates
0

73 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2010: 5 descendants cleared2007: 5 descendants cleared2005: 1 descendant cleared2009: 5 descendants cleared2002: 2 descendants cleared2003: 2 descendants cleared2014: 2 descendants cleared2012: 4 descendants cleared2011: 3 descendants cleared2008: 2 descendants cleared2013: 3 descendants cleared2018: 4 descendants cleared2015: 7 descendants cleared2017: 1 descendant cleared2019: 3 descendants cleared2016: 3 descendants cleared2021: 6 descendants cleared2025: 3 descendants cleared2020: 1 descendant cleared2024: 5 descendants cleared2023: 1 descendant cleared2022: 2 descendants cleared2026: 3 descendants cleared200020052010201520202025
  1. This deviceK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
  2. Descendant · cites it directly · 64 of its ownK030708 Slendertone Flex Abdominal Training System, Type 515Bio-Medical Research, Ltd. · 2003
  3. Descendant · cites it directly · 53 of its ownK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
  4. Descendant · cites it directly · 52 of its ownK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
  5. Descendant · 2 generations on · 32 of its ownK061914 Sport-Elec, Models Duo CT5 Slimness and CT5 SlimnessSport-Elec S.A. · 2007
  6. Descendant · 3 generations on · 31 of its ownK081026 Body Control System Family, Body Control Duo and CT5Sport-Elec S.A. · 2008

Showing 5 of 73 descendants. See all descendants

Descendants cleared per year

2002: 22003: 22005: 12007: 52008: 22009: 52010: 52011: 32012: 42013: 32014: 22015: 72016: 32017: 12018: 42019: 32020: 12021: 62022: 22023: 12024: 52025: 32026: 3
2002high 7 (2015) · low 0 (2004)2026

Most influential descendants

Showing 5 of 73 · See all
  • K030708Slendertone Flex Abdominal Training System, Type 515Bio-Medical Research, Ltd. · 2003 · cites it directly64descendants
  • K022855Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003 · cites it directly53descendants
  • K070142Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts, Models 390, E20Bio-Medical Research Corp. · 2007 · cites it directly52descendants
  • K061914Sport-Elec, Models Duo CT5 Slimness and CT5 SlimnessSport-Elec S.A. · 2007 · 2 generations on32descendants
  • K081026Body Control System Family, Body Control Duo and CT5Sport-Elec S.A. · 2008 · 3 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010335Slendertone Flex, Model, 512Bio-Medical Research, Ltd.2001—
+1K030708Slendertone Flex Abdominal Training System, Type 515Bio-Medical Research, Ltd.2003—
+1K022855Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd.2003—
+1K070142Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts…Bio-Medical Research Corp.2007—
+2K061914Sport-Elec, Models Duo CT5 Slimness and CT5 SlimnessSport-Elec S.A.2007—
+3K081026Body Control System Family, Body Control Duo and CT5Sport-Elec S.A.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200320
200510
200750
200820
200950
201050
201130
201240
201330
201420
201570
201630
201710
201840
201930
202010
202160
202220
202310
202450
202530
202630
FIG. 1 — Lineage of K010335, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K250146 SofWave Systemscore 15.5 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (73)

See all 73

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K030708Slendertone Flex Abdominal Training System, Type 515Bio-Medical Research, Ltd.200364
K022855Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd.200353
K070142Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts, Models 390, E20Bio-Medical Research Corp.200752
K091833Gem-Stone Abdominal Training System; Model Gem-Tone 310PE/320PE/330PE/340PE/350PE.Gemore Technology Co, Ltd.20091
K093368Butterfly Toner Model GYM070Global Marketing Partners Dba Gymmax USA20100
K072168Otc Abdomen & Thigh System, Model: WL-2410, WL-2411 and WL-2412Well-Life Healthcare Limited20070
K052969Slendertone Gymbody, Model 512-01Bio-Medical Research, Ltd.20050
K020427AB BeltThe Dezac Group20020
K020429AB Belt ProThe Dezac Group20020

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?

  • Of its descendants, K030708 (Bio-Medical Research, Ltd., 2003) has gone furthest, with 64 descendants of its own.

How does its category compare?

All NGX devices

NGX Stimulator, Muscle, Powered, For Muscle Conditioning: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NGX

15in 2025

2007: 72008: 32009: 42010: 62011: 52012: 32013: 62014: 62015: 92016: 42017: 102018: 62019: 142020: 112021: 122022: 62023: 122024: 122025: 152026 (partial year): 4
2007high 15 (2025) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NGX

93in 2025

2007: 135 days median2008: 209 days median2009: 132 days median2010: 180 days median2011: 291 days median2012: 362 days median2013: 269 days median2014: 298 days median2015: 184 days median2016: 240 days median2017: 108 days median2018: 104 days median2019: 167 days median2020: 207 days median2021: 256 days median2022: 307 days median2023: 96 days median2024: 207 days median2025: 93 days median2026 (partial year): 118 days median
2007high 362 (2012) · low 93 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NGX

2in 2013

2013: 2
2007high 2 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NGX

15in 2025

2011: 12013: 12015: 72016: 212017: 22018: 62019: 42020: 72021: 52022: 72023: 82024: 112025: 15
2007high 21 (2016) · low 0 (2007)2025

MAUDE reports naming product code NGX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007713500
2008320900
2009413200
2010618000
2011529101
2012336200
2013626921
2014629800
2015918407
20164240021
20171010802
2018610406
20191416704
20201120707
20211225605
2022630707
2023129608
202412207011
20251593015
202641180—

More from Bio-Medical Research, Ltd.

32 FDA decisions under this applicant name. See the company

  • K203513SLENDERTONE Evolve Abs, Type 735Bio-Medical Research, Ltd. · 2021
  • DEN170049InnovoBio-Medical Research, Ltd. · 2018
  • K180688SLENDERTONE CoreFit Abs 8, Type 734Bio-Medical Research, Ltd. · 2018
  • K161974SLENDERTONE® Connect Abs, Type 570Bio-Medical Research, Ltd. · 2016
  • K151903Slendertone connect AbsBio-Medical Research, Ltd. · 2015

Recent decisions in NGX

The NGX category page

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  • K253636Zionic Pro Max (EMS)Termosalud S.L. · 2026
  • K253408CoolToneZimmer Medizinsysteme GmbH · 2026
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https://510kreport.com/device/K010335 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010335: Slendertone Flex, Model, 512.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010335

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026