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FDA 510(k)

Accu-Chek Solo micropump system with interoperable technology

K-Number: K213134 · 2023-08-10

ApplicantRoche Diabetes Care GmbH
Decision Date2023-08-10
Product CodeQFG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Accu-Chek Solo micropump system with interoperable technology is a medical device manufactured by Roche Diabetes Care GmbH. It received FDA 510(k) clearance on 2023-08-10 under approval number K213134. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Accu-Chek Solo micropump system with interoperable technology?

Accu-Chek Solo micropump system with interoperable technology is a medical device that received FDA 510(k) clearance on 2023-08-10. It is manufactured by Roche Diabetes Care GmbH. The 510(k) number is K213134.

When was Accu-Chek Solo micropump system with interoperable technology approved by the FDA?

Accu-Chek Solo micropump system with interoperable technology received FDA 510(k) clearance on 2023-08-10, under approval number K213134.

What company makes Accu-Chek Solo micropump system with interoperable technology?

Accu-Chek Solo micropump system with interoperable technology is manufactured by Roche Diabetes Care GmbH.

What is the FDA product code for Accu-Chek Solo micropump system with interoperable technology?

The FDA product code for Accu-Chek Solo micropump system with interoperable technology is QFG.

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025) PMID: 40837401 Mining and evaluation of security alert signals of neuroprotective agents based on the Jinan adverse event reporting system database: a retrospective study. Frontiers in pharmacology (2025) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Roche Diabetes Care GmbH

K213131Accu-Chek Guide Solo diabetes manager blood glucose monitoring system

Related Devices (Code: QFG)

K191679Omnipod DASH Insulin Management System with interoperable technologyInsulet Corporation DEN180058t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc. K201214t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. K203234t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)Tandem Diabetes Care, Inc. K203768Omnipod 5 ACE Pump (Pod)Insulet Corporation K230545Inessa SystemTriple Jump Israel , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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