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FDA 510(k)

iLet® Dosing Decision Software

K-Number: K220916 · 2023-05-19

ApplicantBeta Bionics, Inc.
Decision Date2023-05-19
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 2023-05-19 under approval number K220916. 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 2023-05-19. It is manufactured by Beta Bionics, Inc.. The 510(k) number is K220916.

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

iLet® Dosing Decision Software received FDA 510(k) clearance on 2023-05-19, under approval number K220916.

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: 42082885 Precision Dosing of Vancomycin: A Systematic Review of Population Pharmacokinetics Models and Comparative Evaluation of Software Tools. Clinical pharmacokinetics (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41883556 A clinician's quick‑start guide to implementing digital health innovations in the NHS - with lessons from a UK-deployed AI stroke imaging decision-support software. Digital health (2026) 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)

Other Devices by Beta Bionics, Inc.

K232224iLet® Dosing Decision Software K231485iLet® ACE Pump K223846iLet® ACE Pump 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. K232224iLet® 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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