510(k) · Cleared
ClearedQuantum Mitohormesis (QMT) (M2101)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantumtx Pte., Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Dec 19, 2024 as substantially equivalent to K151834 (Bemer Int AG, 2017) and 1 other predicate after a 318-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Dec 19, 2024
- Review
- 318 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K940301 (1994). 28 ancestors in all, the oldest K872976 (1987). No later device cites it as a predicate yet.
- Root · 8 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 7 generations backK011880 Compex SportCompex S.A. · 2002
- 6 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 5 generations backK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- 4 generations backK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
- 3 generations backK143207 Revitive IX (OTC)Actegy, Ltd. · 2015
- 2 generations backK151834 BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2017 · Recalled
- 1 generation backK203710 Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG · 2021
- This deviceK240348 Quantum Mitohormesis (QMT) (M2101)Quantumtx Pte., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −7 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −6 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −5 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| −4 | K122744 | Prospera Otc Tens Electronic Pulse Massager | Prospera Corporation | 2013 | — |
| −3 | K143207 | Revitive IX (OTC) | Actegy, Ltd. | 2015 | — |
| −2 | K151834 | BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2017 | 1 |
| −1 | K203710 | Storz Medical MAGNETOLITH Muscle Stimulator | Storz Medical AG | 2021 | — |
| 0 (this device) | 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 |
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 19.7 · 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 |
|---|---|---|---|
| * | K151834 | BEMER Classic Set, BEMER Pro-SetSummary page 5…Classification Panel: Physical Medicine Device Class: Class II Product Code: IPF, NGX Primary Predicate Device: Bemer Classic & Pro (K151834) Regulation number: 21 CFR 890.5850 Regulation Name: Powered Muscle Sti… | 2017 |
| * | K203710 | Storz Medical MAGNETOLITH Muscle StimulatorSummary page 5…: NGX Review panel: Physical Medicine Secondary Predicate Device: Storz Medical MAGNETOLITH Muscle Stimulator (K203710) Regulation number: 21 CFR 890.5850 Regulation Name: Powered Muscle Sti… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 9 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 28 ancestors has a recall of any class.
- 4 other devices also cite its predicate K151834.
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?
Quantum Mitohormesis Medical Device is intended for:
Stimulating healthy limb muscles to improve and facilitate muscle performance.
Preventing or retardation of disuse atrophy of muscles.
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/K240348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240348: Quantum Mitohormesis (QMT) (M2101).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240348
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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