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# Tidepool 510(k) for iPhone Insulin Dosing App
- URL: https://www.fdaweb.com/tidepool-510-k-for-iphone-insulin-dosing-app/
- Published: 2021-01-07T12:00:00.000Z
- Updated: 2026-09-14T16:41:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148402

Tidepool, an open source diabetes nonprofit, has submitted a 510(k) for an automated insulin dosing app for use on the iPhone for managing Type 1 diabetes. The agency has told the company that the submission had completed FDA’s administrative acceptance review and was proceeding to substantive review as an interoperable automated glycemic controller. The app is designed to connect with a variety of compatible insulin pumps and continuous glucose monitoring systems to automatically dose insulin for treating insulin-requiring diabetes by keeping a user’s glucose within a desired correction range, the company says. Tidepool Loop was initially supported by grants from [JDRF](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.jdrf.org%2F&esheet=52357906&newsitemid=20210107005324&lan=en-US&anchor=JDRF&index=1&md5=cd713518175fc496c91d831db8135255&ref=fdaweb.com) (former Juvenile Diabetes Research Foundation) and [The Leona M. and Harry B. Helmsley Charitable Trust](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fhelmsleytrust.org%2F&esheet=52357906&newsitemid=20210107005324&lan=en-US&anchor=The+Leona+M.+and+Harry+B.+Helmsley+Charitable+Trust&index=2&md5=61096e32a2f034089a9b42f51daec560&ref=fdaweb.com).