Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Eko Devices, Inc. with 6 510(k) clearances and 2 AI-enabled devices. The most recent is a 510(k) clearance dated May 26, 2023: CORE 500 Digital Stethoscope.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 26, 2023 | CORE 500 Digital StethoscopeK230111 · DQD | 510(k) clearances |
| Jun 29, 2022 | Eko Murmur Analysis Software (EMAS)K213794 · DQD | 510(k) clearances |
| Jun 29, 2022 | Eko Murmur Analysis Software (EMAS)K213794 · Cardiovascular | AI-enabled devices |
| Apr 6, 2020 | Eko COREK200776 · DQD | 510(k) clearances |
| Jan 15, 2020 | Eko Analysis SoftwareK192004 · MWI | 510(k) clearances |
| Jan 15, 2020 | Eko Analysis SoftwareK192004 · Cardiovascular | AI-enabled devices |
| May 19, 2017 | Eko Model E5 System (EME5), Eko DUOK170874 · DQD | 510(k) clearances |
| Aug 28, 2015 | Eko Electronic Stethoscope SystemK151319 · DQD | 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
