Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
InMode , Ltd. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
117 daysmedian FDA review time
267 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251254 | Ignite RF System | InMode , Ltd. | 2026-01-15 | 267 | 0 |
| K251632 | Optimas MAX System | InMode , Ltd. | 2025-06-26 | 29 | 0 |
| K242598 | DEFINE System (AG612444A) | InMode , Ltd. | 2024-11-14 | 76 | 0 |
| K240780 | InMode RF System | InMode , Ltd. | 2024-07-24 | 125 | 0 |
| K240017 | InMode System with the Morpheus8 90 Applicator | InMode , Ltd. | 2024-06-13 | 163 | 0 |
| K233642 | InMode RF System | InMode , Ltd. | 2024-03-20 | 128 | 0 |
| K231495 | The Evolve System with the Transform Applicator | InMode , Ltd. | 2023-10-13 | 143 | 0 |
| K231790 | The InMode System with the Morpheus8 Applicators | InMode , Ltd. | 2023-07-20 | 30 | 0 |
| K221571 | InMode Multi-system | InMode , Ltd. | 2022-06-30 | 30 | 0 |
| K210877 | Evolve System with the T3 Applicator | InMode , Ltd. | 2021-07-19 | 117 | 0 |
| K201285 | InMode Evolve System with the Tone Applicator | InMode , Ltd. | 2021-03-05 | 296 | 0 |
| K201150 | InMode RF Multi-System | InMode , Ltd. | 2020-07-22 | 84 | 0 |
| K200947 | InMode System with the Morhpeus8 Applicators | InMode , Ltd. | 2020-07-02 | 85 | 0 |
| K200293 | InMode System with vTone Applicator | InMode , Ltd. | 2020-05-05 | 90 | 0 |
| K192249 | InMode System with Tone Applicator | InMode , Ltd. | 2019-12-17 | 120 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda