510(k) · Cleared
ClearedStorz Medical MAGNETOLITH Muscle Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Storz Medical AG · IPF Stimulator, Muscle, Powered
Cleared on May 3, 2021 as substantially equivalent to K160992 (BTL Industries, Inc., 2016) and 1 other predicate after a 133-day review. Its family tree reaches back 7 generations to 1994. 4 later devices descend from it.
- Decided
- May 3, 2021
- Review
- 133 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K940301 (1994). 27 ancestors in all, the oldest K872976 (1987). 4 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 6 generations backK011880 Compex SportCompex S.A. · 2002
- 5 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 4 generations backK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- 3 generations backK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
- 2 generations backK143207 Revitive IX (OTC)Actegy, Ltd. · 2015
- 1 generation backK151834 BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2017 · Recalled
- This deviceK203710 Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG · 2021
- Descendant · cites it directly · 2 of its ownK240234 BTL-899MSBTL Industries, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK253408 CoolToneZimmer Medizinsysteme GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK251594 truFlexSyrma Johari Medtech Limited · 2025
- Descendant · cites it directly · 0 of its ownK240348 Quantum Mitohormesis (QMT) (M2101)Quantumtx Pte., Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K240234BTL-899MSBTL Industries, Inc. · 2024 · cites it directly2descendants
- K253408CoolToneZimmer Medizinsysteme GmbH · 2026 · 2 generations on0descendants
- K251594truFlexSyrma Johari Medtech Limited · 2025 · 2 generations on0descendants
- K240348Quantum Mitohormesis (QMT) (M2101)Quantumtx Pte., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −6 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −5 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −4 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| −3 | K122744 | Prospera Otc Tens Electronic Pulse Massager | Prospera Corporation | 2013 | — |
| −2 | K143207 | Revitive IX (OTC) | Actegy, Ltd. | 2015 | — |
| −1 | K151834 | BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2017 | 1 |
| 0 (this device) | K203710 | Storz Medical MAGNETOLITH Muscle Stimulator | Storz Medical AG | 2021 | — |
| +1 | K240234 | BTL-899MS | BTL Industries, Inc. | 2024 | — |
| +2 | K253408 | CoolTone | Zimmer Medizinsysteme GmbH | 2026 | — |
| +2 | K251594 | truFlex | Syrma Johari Medtech Limited | 2025 | — |
| +1 | K240348 | Quantum Mitohormesis (QMT) (M2101) | Quantumtx Pte., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K160992 | HPM-6000Summary page 4…roduct Code: IPF, NGX Regulatory Class: II 3. PREDICATE DEVICES Equivalence is claimed to the following predicate devices: HPM-6000 (K160992, primary), and Bemer Classic & Pro (K151834, secondary). 4. DEVICE DESCRIPTION The MAGNETOLITH delivers electrom… | 2016 |
| * | K151834 | BEMER Classic Set, BEMER Pro-SetSummary page 4…Class: II 3. PREDICATE DEVICES Equivalence is claimed to the following predicate devices: HPM-6000 (K160992, primary), and Bemer Classic & Pro (K151834, secondary). 4. DEVICE DESCRIPTION The MAGNETOLITH delivers electromagnetic pulses to stimulate muscle tissues b y… | 2017 |
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 27 years and passes through 8 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K240234 (BTL Industries, Inc., 2024) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K160992.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
The MAGNETOLITH Muscle Stimulator is indicated for:
-Relaxation of muscle spasms,
-Prevention or retardation of disuse atrophy,
-Increase 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/K203710 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203710: Storz Medical MAGNETOLITH Muscle Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203710
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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