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FDA 510(k)

iLet® Dosing Decision Software

K-Number: K232224 · 2023-09-22

ApplicantBeta Bionics, Inc.
Decision Date2023-09-22
Product CodeQJI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

iLet® Dosing Decision Software is a medical device manufactured by Beta Bionics, Inc.. It received FDA 510(k) clearance on 2023-09-22 under approval number K232224. 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 iLet® Dosing Decision Software?

iLet® Dosing Decision Software is a medical device that received FDA 510(k) clearance on 2023-09-22. It is manufactured by Beta Bionics, Inc.. The 510(k) number is K232224.

When was iLet® Dosing Decision Software approved by the FDA?

iLet® Dosing Decision Software received FDA 510(k) clearance on 2023-09-22, under approval number K232224.

What company makes iLet® Dosing Decision Software?

iLet® Dosing Decision Software is manufactured by Beta Bionics, Inc..

What is the FDA product code for iLet® Dosing Decision Software?

The FDA product code for iLet® Dosing Decision Software is QJI.

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 38767890 Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety. Journal of the American Medical Informatics Association : JAMIA (2024) PMID: 37579360 Impact of the Regulatory Framework on Medical Device Software Manufacturers: Are the Guidance Documents Supporting the Practical Implementation? Comment on "Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We Ready for It? - A Viewpoint Paper". International journal of health policy and management (2023) PMID: 25776925 Regulatory Framework for Clinical Decision Support Software: Present Uncertainty and Prospective Proposition. Journal of the American College of Radiology : JACR (2015)

Other Devices by Beta Bionics, Inc.

K231485iLet® ACE Pump K223846iLet® ACE Pump K220916iLet® Dosing Decision Software K252770iLet ACE Pump K253976iLet ACE Pump

Related Devices (Code: QJI)

DEN190034Control-IQ TechnologyTandem Diabetes Care, Inc. K200467Control-IQ TechnologyTandem Diabetes Care, Inc. K220394SmartAdjust(TM) technologyInsulet Corporation K203774SmartAdjust technologyInsulet Corporation K232382Control-IQ TechnologyTandem Diabetes Care, Inc. K220916iLet® Dosing Decision SoftwareBeta Bionics, Inc.

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.

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