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 its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Cala Health with 6 510(k) clearances. The most recent is a 510(k) clearance dated Mar 17, 2026: Cala kIQ Plus.
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.
| Mar 17, 2026 | Cala kIQ PlusK253587 · QBC | 510(k) clearances |
| Jan 16, 2025 | Cala kIQK243848 · QBC | 510(k) clearances |
| Nov 22, 2024 | Cala kIQK242259 · QBC | 510(k) clearances |
| Nov 22, 2022 | Cala kIQK222237 · QBC | 510(k) clearances |
| Oct 5, 2021 | Cala TrioK203288 · QBC | 510(k) clearances |
| Oct 25, 2018 | External upper limb tremor stimulatorK182706 · QBC | 510(k) clearances |
| Apr 26, 2018 | Cala ONEDEN170028 · QBC | 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
