Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled 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 15, 2026, FDA's public records list Healthy.io with 4 510(k) clearances and 4 AI-enabled devices. The most recent is a 510(k) clearance dated Sep 8, 2023: Minuteful-kidney test.
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.
| Sep 8, 2023 | Minuteful-kidney testK222921 · JIR | 510(k) clearances |
| Sep 8, 2023 | Minuteful-kidney testK222921 · Clinical Chemistry | AI-enabled devices |
| Jul 6, 2022 | Minuteful - kidney testK210069 · JIR | 510(k) clearances |
| Jul 6, 2022 | Minuteful - kidney testK210069 · Clinical Chemistry | AI-enabled devices |
| Jul 26, 2019 | ACR LAB Urine Analysis Test SystemK182384 · JFY | 510(k) clearances |
| Jul 26, 2019 | ACR LAB Urine Analysis Test SystemK182384 · Clinical Chemistry | AI-enabled devices |
| Jul 18, 2018 | DIP/U.S. Urine Analysis Test SystemK173327 · JIL | 510(k) clearances |
| Jul 18, 2018 | DIP/U.S. Urine Analysis Test SystemK173327 · Clinical Chemistry | AI-enabled devices |
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
