510(k) · Cleared
ClearedBTL-899MS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BTL Industries, Inc. · IPF Stimulator, Muscle, Powered
Cleared on Aug 17, 2024 as substantially equivalent to K203488 (Zimmer Medizinsysteme GmbH, 2021) and 2 other predicates after a 201-day review. Its family tree reaches back 9 generations to 2001. 2 later devices descend from it.
- Decided
- Aug 17, 2024
- Review
- 201 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K010335 (2001). 46 ancestors in all, the oldest K872976 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 5 generations between
- 3 generations backK182106 BTL 799-2TBTL Industries, Inc. · 2018
- 2 generations backK190456 BTL 799-2LBTL Industries, Inc. · 2019
- 1 generation backK200382 BTL-703-2Btl · 2021
- This deviceK240234 BTL-899MSBTL Industries, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK253408 CoolToneZimmer Medizinsysteme GmbH · 2026
- Descendant · cites it directly · 0 of its ownK251594 truFlexSyrma Johari Medtech Limited · 2025
Show all 9 generations
- Root · 9 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 8 generations backK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
- 7 generations backK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
- 6 generations backK072553 System-Arms, Model 390,E60Bio-Medical Research, Ltd. · 2007
- 5 generations backK091865 Sport-Elec Body Control SystemSport-Elec · 2009
- 4 generations backK092476 Sport-Elec Body Control System, Model 4MSport-Elec · 2010
- 3 generations backK182106 BTL 799-2TBTL Industries, Inc. · 2018
- 2 generations backK190456 BTL 799-2LBTL Industries, Inc. · 2019
- 1 generation backK200382 BTL-703-2Btl · 2021
- This deviceK240234 BTL-899MSBTL Industries, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| −8 | K022855 | Slendertone Flex Bottom & Thigh Toning System, Type 511 | Bio-Medical Research, Ltd. | 2003 | — |
| −7 | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts… | Bio-Medical Research Corp. | 2007 | — |
| −6 | K072553 | System-Arms, Model 390,E60 | Bio-Medical Research, Ltd. | 2007 | — |
| −5 | K091865 | Sport-Elec Body Control System | Sport-Elec | 2009 | — |
| −4 | K092476 | Sport-Elec Body Control System, Model 4M | Sport-Elec | 2010 | — |
| −3 | K182106 | BTL 799-2T | BTL Industries, Inc. | 2018 | — |
| −2 | K190456 | BTL 799-2L | BTL Industries, Inc. | 2019 | — |
| −1 | K200382 | BTL-703-2 | Btl | 2021 | — |
| 0 (this device) | K240234 | BTL-899MS | BTL Industries, Inc. | 2024 | — |
| +1 | K253408 | CoolTone | Zimmer Medizinsysteme GmbH | 2026 | — |
| +1 | K251594 | truFlex | Syrma Johari Medtech Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.6 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K203488 | emFieldSummary page 5…ng 510(k) Premarket Notification numbers: Primary predicate: Device name: emField Original 510(k) Sponsor: Zimmer MedizinSysteme GmbH 510(k) Number: K203488 Second predicate: Device name: BTL-703-2 Original 510(k) Sponsor: BTL Industries, Inc 510(k) Number: K2003… | 2021 |
| * | K200382 | BTL-703-2Summary page 5…zinSysteme GmbH 510(k) Number: K203488 Second predicate: Device name: BTL-703-2 Original 510(k) Sponsor: BTL Industries, Inc 510(k) Number: K200382 Third predicate: Device name: MAGNETOLITH Original 510(k) Sponsor: Storz Medical AG 510(k) Number: K203710… | 2021 |
| * | K203710 | Storz Medical MAGNETOLITH Muscle StimulatorSummary page 5…L Industries, Inc 510(k) Number: K200382 Third predicate: Device name: MAGNETOLITH Original 510(k) Sponsor: Storz Medical AG 510(k) Number: K203710 Product Description The BTL-899MS is a non-invasive therapeutic device. The device is comprised of a main unit and applicators… | 2021 |
What descends from it? (2)
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 23 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 46 ancestors has a recall of any class.
- Of its descendants, K253408 (Zimmer Medizinsysteme GmbH, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
BTL-899MS 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. The BTL-899MS device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. The BTL-899MS device is…
Read the full statement (123 words)
BTL-899MS 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.
The BTL-899MS device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
The BTL-899MS device is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.
Indications for Use for Muscle Stimulators:
Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240234: BTL-899MS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240234
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