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FDA 510(k)

Precision Delivery Infusion Set

K-Number: K202672 · 2021-01-21

ApplicantQuest Medical, Inc.
Decision Date2021-01-21
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Precision Delivery Infusion Set is a medical device manufactured by Quest Medical, Inc.. It received FDA 510(k) clearance on 2021-01-21 under approval number K202672. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Precision Delivery Infusion Set?

Precision Delivery Infusion Set is a medical device that received FDA 510(k) clearance on 2021-01-21. It is manufactured by Quest Medical, Inc.. The 510(k) number is K202672.

When was Precision Delivery Infusion Set approved by the FDA?

Precision Delivery Infusion Set received FDA 510(k) clearance on 2021-01-21, under approval number K202672.

What company makes Precision Delivery Infusion Set?

Precision Delivery Infusion Set is manufactured by Quest Medical, Inc..

What is the FDA product code for Precision Delivery Infusion Set?

The FDA product code for Precision Delivery Infusion Set is FPA.

Related Clinical Trials

NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING NCT07575191 Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer NOT_YET_RECRUITING NCT01857934 Therapy for Children With Advanced Stage Neuroblastoma COMPLETED NCT03581721 Prevention of Maternal Hypothermia After Scheduled Caesarean Section Using Active Intravenous Warming COMPLETED NCT07501650 Pembrolizumab Plus Ultrasound-Induced Microbubble Cavitation in Head and Neck Cancer RECRUITING

Related PubMed Literature

PMID: 41813232 Artificial Intelligence Applications in Medical Devices for Personalized Health Care Solutions: Systematic Review. Journal of medical Internet research (2026)

Other Devices by Quest Medical, Inc.

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Related Devices (Code: FPA)

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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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