FDA 510(k)

Tidepool Loop

K-Number: K203689 · 2023-01-23

Decision Date2023-01-23

Product CodeQJI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Tidepool Loop is the device name listed in this FDA 510(k) record. The listed applicant is Tidepool Project. It received FDA 510(k) clearance on 2023-01-23 under 510(k) number K203689. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tidepool Loop?

Tidepool Loop is a medical device that received FDA 510(k) clearance on 2023-01-23. The listed applicant is Tidepool Project. The 510(k) number is K203689.

When did Tidepool Loop receive FDA 510(k) clearance?

Tidepool Loop received FDA 510(k) clearance on 2023-01-23, under 510(k) number K203689.

Who is the listed applicant for Tidepool Loop?

The FDA 510(k) record lists Tidepool Project as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tidepool Loop?

The FDA product code for Tidepool Loop is QJI.

Related Devices (Code: QJI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed K261461Omnipod 6 algorithmInsulet Corporation K260429Control-IQ+ technologyTandem Diabetes Care, Inc.K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed K253585SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc.K251152DBLG2Diabeloop

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.