510(k) · Cleared
ClearedBTL 799-2L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BTL Industries, Inc. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Jul 5, 2019 as substantially equivalent to K182106 (BTL Industries, Inc., 2018) and 1 other predicate after a 130-day review. Its family tree reaches back 7 generations to 2001. 11 later devices descend from it.
- Decided
- Jul 5, 2019
- Review
- 130 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K010335 (2001). 18 ancestors in all, the oldest K952089 (1995). 11 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 6 generations backK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
- 5 generations backK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
- 4 generations backK072553 System-Arms, Model 390,E60Bio-Medical Research, Ltd. · 2007
- 3 generations backK091865 Sport-Elec Body Control SystemSport-Elec · 2009
- 2 generations backK092476 Sport-Elec Body Control System, Model 4MSport-Elec · 2010
- 1 generation backK182106 BTL 799-2TBTL Industries, Inc. · 2018
- This deviceK190456 BTL 799-2LBTL Industries, Inc. · 2019
- Descendant · cites it directly · 4 of its ownK200382 BTL-703-2Btl · 2021
- Descendant · 2 generations on · 2 of its ownK240234 BTL-899MSBTL Industries, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK250038 Muscle Stimulator Device (PZ-100)Zhengzhou PZ Laser Slim Technology Co., Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK232181 Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)Hebei JT Medical Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK253790 High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology Limited · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K200382BTL-703-2Btl · 2021 · cites it directly4descendants
- K240234BTL-899MSBTL Industries, Inc. · 2024 · 2 generations on2descendants
- K250038Muscle Stimulator Device (PZ-100)Zhengzhou PZ Laser Slim Technology Co., Ltd. · 2025 · cites it directly1descendant
- K232181Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)Hebei JT Medical Co., Ltd. · 2024 · cites it directly1descendant
- K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology Limited · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| −6 | K022855 | Slendertone Flex Bottom & Thigh Toning System, Type 511 | Bio-Medical Research, Ltd. | 2003 | — |
| −5 | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts… | Bio-Medical Research Corp. | 2007 | — |
| −4 | K072553 | System-Arms, Model 390,E60 | Bio-Medical Research, Ltd. | 2007 | — |
| −3 | K091865 | Sport-Elec Body Control System | Sport-Elec | 2009 | — |
| −2 | K092476 | Sport-Elec Body Control System, Model 4M | Sport-Elec | 2010 | — |
| −1 | K182106 | BTL 799-2T | BTL Industries, Inc. | 2018 | — |
| 0 (this device) | K190456 | BTL 799-2L | BTL Industries, Inc. | 2019 | — |
| +1 | K200382 | BTL-703-2 | Btl | 2021 | — |
| +2 | K240234 | BTL-899MS | BTL Industries, Inc. | 2024 | — |
| +1 | K250038 | Muscle Stimulator Device (PZ-100) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025 | — |
| +1 | K232181 | Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) | Hebei JT Medical Co., Ltd. | 2024 | — |
| +2 | K253790 | High Intensity Focused Electromagnetic Stimulation Device (FE60) | Beijing Winkonlaser Technology Limited | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K182106 | BTL 799-2TSummary page 4…to the current products that are already cleared for distribution in the USA under the following 510(k) Premarket Notification number: primary predicate 799-2T (K182106) 510(k) Summary - Page 1 of 6 secondary predicate HPM-6000 (K16… | 2018 |
| * | K160992 | HPM-6000Summary page 5…: primary predicate 799-2T (K182106) 510(k) Summary - Page 1 of 6 secondary predicate HPM-6000 (K160992) Product Description The BTL 799-2L is a non-invasive therapeutic device. The device produces electromagnetic field that intera… | 2016 |
What descends from it? (11)
See all 115 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 18 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K200382 (Btl, 2021) has gone furthest, with 4 descendants of its own.
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. 2019, 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?
BTL 799-2L is indicated to be used for:
• Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
• Strengthening, Toning and Firming of buttocks, thighs and calves.
• Improvement of muscle tone and firmness, for strengthening muscles in arms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190456 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190456: BTL 799-2L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190456
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