510(k) · Cleared
ClearedInMode System with Tone Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
InMode, Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Dec 17, 2019 as substantially equivalent to K132284 (Djo, LLC, 2014) after a 120-day review. Its family tree reaches back 3 generations to 1995. 9 later devices descend from it.
- Decided
- Dec 17, 2019
- Review
- 120 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945509 (1995). 5 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK945509 FX-2 NMS (2CHANNEL Table Model)Fx-2 · 1995
- 2 generations backK062354 Vectra Genisys VMS FREncore Medical L.P. · 2007
- 1 generation backK132284 Vectra Neo Clinical Therapy SystemDjo, LLC · 2014
- This deviceK192249 InMode System with Tone ApplicatorInMode, Ltd. · 2019
- Descendant · cites it directly · 6 of its ownK201285 InMode Evolve System with the Tone ApplicatorInMode, Ltd. · 2021
- Descendant · 2 generations on · 5 of its ownK210877 Evolve System with the T3 ApplicatorInMode, Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK241433 EVE Synergy (EVE-20M)Weero Co., Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK202079 PhysiqEl.En Electronic Engineering Spa · 2020
- Descendant · 3 generations on · 0 of its ownK253542 Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd. · 2021 · cites it directly6descendants
- K210877Evolve System with the T3 ApplicatorInMode, Ltd. · 2021 · 2 generations on5descendants
- K241433EVE Synergy (EVE-20M)Weero Co., Ltd. · 2025 · 2 generations on1descendant
- K202079PhysiqEl.En Electronic Engineering Spa · 2020 · cites it directly1descendant
- K253542Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945509 | FX-2 NMS (2CHANNEL Table Model) | Fx-2 | 1995 | — |
| −2 | K062354 | Vectra Genisys VMS FR | Encore Medical L.P. | 2007 | — |
| −1 | K132284 | Vectra Neo Clinical Therapy System | Djo, LLC | 2014 | — |
| 0 (this device) | K192249 | InMode System with Tone Applicator | InMode, Ltd. | 2019 | — |
| +1 | K201285 | InMode Evolve System with the Tone Applicator | InMode, Ltd. | 2021 | — |
| +2 | K210877 | Evolve System with the T3 Applicator | InMode, Ltd. | 2021 | — |
| +2 | K241433 | EVE Synergy (EVE-20M) | Weero Co., Ltd. | 2025 | — |
| +1 | K202079 | Physiq | El.En Electronic Engineering Spa | 2020 | — |
| +3 | K253542 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 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? (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 |
|---|---|---|---|
| * | K132284 | Vectra Neo Clinical Therapy SystemSummary page 4…te device. Predicate Manufacturer 510(k) No. Vectra Neo Clinical Therapy System DJO, LLC K132284 InMode System with Tone Applicators 510(k) file Page 05-2 Section 05 – 510(k) Summ… | 2014 |
What descends from it? (9)
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 24 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K201285 (InMode, Ltd., 2021) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K132284.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 InMode System with Tone Applicator is used in EMS mode for:
Prevention or retardation of disuse atrophy
Maintaining or increasing range of motion
Muscle re-education
Relaxation of muscle spasms
Increasing local blood circulation
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
And in TENS mode for:
Symptomatic relief and management of chronic, intractable pain
Post-surgical acute pain
Post-traumatic acute pain
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192249: InMode System with Tone Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192249
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