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Sweetspot Diabetes Data Management Service

by Sweetspot Diabetes Care, Inc.

510(k) K111509

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111509 Date9 Nov 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NBW
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Sweetspot Diabetes Data Management Service is a centralized software platform for managing diabetes device data from CGMs and insulin pumps, combined with virtual, wrap-around clinical support services. It is designed to enable remote review of patient data by healthcare providers to identify trends in blood glucose levels outside of clinical appointments.

The service is supplied as a software-based platform with associated clinical support from Certified Diabetes Care and Education Specialists (CDCES). It is used in outpatient or home care settings to facilitate treatment plan changes through monthly data reviews and coordination between patients and providers. The device received FDA 510(k) clearance (K111509) on November 9, 2011, and is classified under product code NBW with advisory committee review in Clinical Chemistry (CH).

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Sweetspot Diabetes Data Management Service used for?

    It is used to manage diabetes device data from CGMs and insulin pumps and provide virtual clinical support from Certified Diabetes Care and Education Specialists to enable remote review of patient data by healthcare providers for identifying blood glucose trends outside of clinical appointments.

  • How is the Sweetspot Diabetes Data Management Service supplied and accessed?

    It is supplied as a software-based platform with associated clinical support from CDCES and is used in outpatient or home care settings to facilitate treatment plan changes through monthly data reviews and coordination between patients and providers.

  • Is the Sweetspot Diabetes Data Management Service a single-use or reusable product?

    As a software-based service with ongoing clinical support, it is designed for continuous, reusable use over time to support ongoing diabetes management rather than being a single-use product.