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)

DEKA ACE Pump System

K-Number: K213536 · 2023-07-25

ApplicantDeka Research and Development
Decision Date2023-07-25
Product CodeQFG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DEKA ACE Pump System is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research and Development. It received FDA 510(k) clearance on 2023-07-25 under 510(k) number K213536. 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 DEKA ACE Pump System?

DEKA ACE Pump System is a medical device that received FDA 510(k) clearance on 2023-07-25. The listed applicant is Deka Research and Development. The 510(k) number is K213536.

When did DEKA ACE Pump System receive FDA 510(k) clearance?

DEKA ACE Pump System received FDA 510(k) clearance on 2023-07-25, under 510(k) number K213536.

Who is the listed applicant for DEKA ACE Pump System?

The FDA 510(k) record lists Deka Research and Development as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEKA ACE Pump System?

The FDA product code for DEKA ACE Pump System is QFG.

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.

NCT06853990Innovative Automated Insulin Delivery System for Type 2 DiabetesCOMPLETED

Other records listing Deka Research and Development 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.

K261672twiist Automated Insulin Delivery (AID) SystemK261530iiSure Infusion SetK243841Sparta Infusion Set for InsulinK241736Remunity 2.0 Pump for Remodulin (treprostinil) InjectionK242693DEKA Infusion System, DEKA Administration SetK240920HemoCare Bicarbonate Concentrate Set (BCS)

View all 14 devices →

Related Devices (Code: QFG)

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.

K261672twiist Automated Insulin Delivery (AID) SystemDeka Research and DevelopmentK253976iLet ACE PumpBeta Bionics, Inc.K253743MiniMed Flex pumpMedtronic Minimed, Inc.K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc.K253074Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc.K252770iLet ACE PumpBeta 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.

↑