510(k) · Cleared
ClearedBTL 799-2
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 Jun 14, 2018 as substantially equivalent to K163165 (BTL Industries, Inc., 2017) after a 77-day review. Its family tree reaches back 3 generations to 2007. 21 later devices descend from it.
- Decided
- Jun 14, 2018
- Review
- 77 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K062439 (2007). 21 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK062439 Powertone, Model PT-11Johari Digital Healthcare, Ltd. · 2007
- 2 generations backK131291 Torc BodyJohari Digital Healthcare, Ltd. · 2013
- 1 generation backK163165 AM-100BTL Industries, Inc. · 2017
- This deviceK180813 BTL 799-2BTL Industries, Inc. · 2018
- Descendant · cites it directly · 12 of its ownK182106 BTL 799-2TBTL Industries, Inc. · 2018
- Descendant · 2 generations on · 11 of its ownK190456 BTL 799-2LBTL Industries, Inc. · 2019
- Descendant · 3 generations on · 4 of its ownK200382 BTL-703-2Btl · 2021
- Descendant · cites it directly · 3 of its ownK182963 emFieldProZimmer Medizinsysteme GmbH · 2019
- Descendant · 4 generations on · 2 of its ownK240234 BTL-899MSBTL Industries, Inc. · 2024
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K182106BTL 799-2TBTL Industries, Inc. · 2018 · cites it directly12descendants
- K190456BTL 799-2LBTL Industries, Inc. · 2019 · 2 generations on11descendants
- K200382BTL-703-2Btl · 2021 · 3 generations on4descendants
- K182963emFieldProZimmer Medizinsysteme GmbH · 2019 · cites it directly3descendants
- K240234BTL-899MSBTL Industries, Inc. · 2024 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K062439 | Powertone, Model PT-11 | Johari Digital Healthcare, Ltd. | 2007 | — |
| −2 | K131291 | Torc Body | Johari Digital Healthcare, Ltd. | 2013 | — |
| −1 | K163165 | AM-100 | BTL Industries, Inc. | 2017 | — |
| 0 (this device) | K180813 | BTL 799-2 | BTL Industries, Inc. | 2018 | — |
| +1 | K182106 | BTL 799-2T | BTL Industries, Inc. | 2018 | — |
| +2 | K190456 | BTL 799-2L | BTL Industries, Inc. | 2019 | — |
| +3 | K200382 | BTL-703-2 | Btl | 2021 | — |
| +1 | K182963 | emFieldPro | Zimmer Medizinsysteme GmbH | 2019 | — |
| +4 | K240234 | BTL-899MS | BTL Industries, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 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? (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 |
|---|---|---|---|
| * | K163165 | AM-100Summary page 4…tantially equivalent to the current product that is already cleared for distribution in the USA under the following 510(k) Premarket Notification number: AM-100 (K163165) 510(k) Summary - Page 1 of 6 Product Description The BTL 799-2 is a non-i… | 2017 |
What descends from it? (21)
See all 216 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 11 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K182106 (BTL Industries, Inc., 2018) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K163165.
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. 2018, 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 799-2 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 and thighs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180813 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180813: BTL 799-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180813
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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