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

FDA 510(k)

Omnipod 6 algorithm

K-Number: K261461 · 2026-06-29

ApplicantInsulet Corporation
Decision Date2026-06-29
Product CodeQJI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Omnipod 6 algorithm is the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corporation. It received FDA 510(k) clearance on 2026-06-29 under 510(k) number K261461. 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 Omnipod 6 algorithm?

Omnipod 6 algorithm is a medical device that received FDA 510(k) clearance on 2026-06-29. The listed applicant is Insulet Corporation. The 510(k) number is K261461.

When did Omnipod 6 algorithm receive FDA 510(k) clearance?

Omnipod 6 algorithm received FDA 510(k) clearance on 2026-06-29, under 510(k) number K261461.

Who is the listed applicant for Omnipod 6 algorithm?

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

What is the FDA product code for Omnipod 6 algorithm?

The FDA product code for Omnipod 6 algorithm is QJI.

Related Clinical Trials

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.

NCT07593625Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1DRECRUITINGNCT06144554Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 DiabetesRECRUITINGNCT07039942French Prospective Multicentric Study in Real WorldACTIVE_NOT_RECRUITINGNCT07039981Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Adults With Type 2 DiabetesCOMPLETEDNCT07317102Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)RECRUITINGNCT07521475Evaluation of the Fully Closed Loop Omnipod® System in Type 2 DiabetesRECRUITING

Other records listing Insulet Corporation as applicant

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.

K251779Omnipod 5 algorithmK241777SmartAdjust™ TechnologyK232741SmartAdjust(TM) technologyK231826Omnipod 5 ACE PumpK231824SmartBolus CalculatorK223372Omnipod GO Insulin Delivery Device

View all 19 devices →

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 MiniMedK260429Control-IQ+ technologyTandem Diabetes Care, Inc.K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MinimedK253585SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc.K251152DBLG2DiabeloopK251779Omnipod 5 algorithmInsulet 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.

↑