Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Modular Medical MODD1 Insulin Delivery System

K-Number: K240158 · 2024-09-04

ApplicantModular Medical, Inc.
Decision Date2024-09-04
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Modular Medical MODD1 Insulin Delivery System is a medical device manufactured by Modular Medical, Inc.. It received FDA 510(k) clearance on 2024-09-04 under approval number K240158. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Modular Medical MODD1 Insulin Delivery System?

Modular Medical MODD1 Insulin Delivery System is a medical device that received FDA 510(k) clearance on 2024-09-04. It is manufactured by Modular Medical, Inc.. The 510(k) number is K240158.

When was Modular Medical MODD1 Insulin Delivery System approved by the FDA?

Modular Medical MODD1 Insulin Delivery System received FDA 510(k) clearance on 2024-09-04, under approval number K240158.

What company makes Modular Medical MODD1 Insulin Delivery System?

Modular Medical MODD1 Insulin Delivery System is manufactured by Modular Medical, Inc..

What is the FDA product code for Modular Medical MODD1 Insulin Delivery System?

The FDA product code for Modular Medical MODD1 Insulin Delivery System is LZG.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41967377 Governing the rise of AI in healthcare: A comparative governance document and implementation implications across five jurisdictions. Social science & medicine (1982) (2026)

Related Devices (Code: LZG)

K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc. K160056t:slim Insulin Delivery SystemTandem Diabetes Care, Inc. K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc. K160252OmniPod Insulin Management SystemInsulet Corporation K162296OmniPod Insulin Management SystemInsulet Corporation K180045Omnipod DASH Insulin Management SystemInsulet Corporation

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.

↑