ACCU-CHEK Connect Diabetes Management App— 510(k) K150910
Substantially EquivalentRoche Diabetes Care, Inc.
FDA 510(k) clearance K150910 for ACCU-CHEK Connect Diabetes Management App, Substantially Equivalent on 2015-06-03. Applicant: Roche Diabetes Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diabetes Care, Inc.
- Product code
- Code NDC
- Device class
- Class 2
- Regulation
- 21 CFR 868.1890
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Indianapolis, IN, US
Recent devices under product code NDC
view allMore clearances from Roche Diabetes Care, Inc.
view allAdverse events under product code NDC
product code NDC- Malfunction
- 1,390
- Total
- 1,390
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K150910
K-number listed on FDA's recall record- Z-2753-2019 — Accu-Chek Connect Diabetes Management App
- Z-0197-2018 — Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017 The Accu-Chek Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format. The Accu-Chek Bolus Advisor, as a component of the Accu-Chek Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data
- Z-0625-2018 — Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017
- Z-1899-2017 — Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available. The number of unique users for each affected version from the date of initial distribution through 03/23/2017 is noted in 7a. However, some users will have used all three affected versions as they upgraded from version to version when the versions became available and many others will have tried the app and discontinued use. In the last 30 days, 02/22/2017 03/23/2017, there have been 16,781 unique users in the US with 264 of those seeking bolus advice and 19,268 unique users in the rest of world (excluding Canada) with 415 of those users seeking bolus advice.
- Z-1099-2017 — Accu-Chek Connect Diabetes Management App
- Z-0586-2017 — Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150910.
Data sourced from openFDA. This site is unofficial and independent of the FDA.