Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 2 companies' records, each linked to the record.
As of Nov 14, 2026, FDA's public records list Revenio Group and its 2 subsidiaries with 20 510(k) clearances. The most recent is a 510(k) clearance dated Mar 17, 2025: MAIA (AHMACME001).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Revenio Group and its 2 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 17, 2025 | MAIA (AHMACME001)K243504 · MYC | 510(k) clearances |
| Sep 27, 2024 | iCare ST500 (TA04)K241447 · HKY | 510(k) clearances |
| Aug 22, 2024 | iCare ALTIUS CWK234076 · NFJ | 510(k) clearances |
| Oct 6, 2022 | iCare IC200K220852 · HKY | 510(k) clearances |
| Jan 25, 2022 | iCare HOME2K211355 · HKY | 510(k) clearances |
| Dec 21, 2021 | DRSplusK213705 · MYC | 510(k) clearances |
| Aug 19, 2021 | EIDON FA, EIDON, EIDON AF, EIDON UWFLK211328 · MYC | 510(k) clearances |
| May 7, 2020 | Icare HOME TonometerK200966 · HKY | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
