Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled 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 14, 2026, FDA's public records list I-Sens, Inc. with 28 510(k) clearances. The most recent is a 510(k) clearance dated Oct 2, 2026: CVS Advanced PLUS Blood Glucose Monitoring System.
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.
| Oct 2, 2026 | CVS Advanced PLUS Blood Glucose Monitoring SystemK260689 · NBW | 510(k) clearances |
| Aug 10, 2023 | ReliOn Premier BLU Blood Glucose Monitoring SystemK230625 · NBW | 510(k) clearances |
| Nov 23, 2022 | LDE4 Lancing DeviceK222656 · QRL | 510(k) clearances |
| Oct 5, 2021 | CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring SystemK201394 · NBW | 510(k) clearances |
| Sep 9, 2020 | KetoSens BT Blood B-Ketone Monitoring SystemK201551 · JIN | 510(k) clearances |
| Jan 24, 2020 | CareSens S Clear BT Blood Glucose Monitoring SystemK192859 · NBW | 510(k) clearances |
| Jan 17, 2020 | CareSens S Fit BT Blood Glucose Monitoring SystemK193590 · NBW | 510(k) clearances |
| Dec 13, 2019 | ReliOn Premier Classic Blood Glucose Monitoring SystemK192220 · NBW | 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
