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FDA 510(k)

SmartAdjust(TM) technology

K-Number: K220394 · 2022-08-19

ApplicantInsulet Corporation
Decision Date2022-08-19
Product CodeQJI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SmartAdjust(TM) technology is the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corporation. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K220394. 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 SmartAdjust(TM) technology?

SmartAdjust(TM) technology is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Insulet Corporation. The 510(k) number is K220394.

When did SmartAdjust(TM) technology receive FDA 510(k) clearance?

SmartAdjust(TM) technology received FDA 510(k) clearance on 2022-08-19, under 510(k) number K220394.

Who is the listed applicant for SmartAdjust(TM) technology?

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 SmartAdjust(TM) technology?

The FDA product code for SmartAdjust(TM) technology is QJI.

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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.

K261461Omnipod 6 algorithmK251779Omnipod 5 algorithmK241777SmartAdjust™ TechnologyK232741SmartAdjust(TM) technologyK231826Omnipod 5 ACE PumpK231824SmartBolus Calculator

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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 MiniMedK261461Omnipod 6 algorithmInsulet CorporationK260429Control-IQ+ technologyTandem Diabetes Care, Inc.K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MinimedK253585SmartGuard 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.

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