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

FDA 510(k)

Q2 Blood Administration Sets

K-Number: K213846 · 2022-06-05

ApplicantQuest Medical, Inc.
Decision Date2022-06-05
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Q2 Blood Administration Sets is a medical device manufactured by Quest Medical, Inc.. It received FDA 510(k) clearance on 2022-06-05 under approval number K213846. 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 Q2 Blood Administration Sets?

Q2 Blood Administration Sets is a medical device that received FDA 510(k) clearance on 2022-06-05. It is manufactured by Quest Medical, Inc.. The 510(k) number is K213846.

When was Q2 Blood Administration Sets approved by the FDA?

Q2 Blood Administration Sets received FDA 510(k) clearance on 2022-06-05, under approval number K213846.

What company makes Q2 Blood Administration Sets?

Q2 Blood Administration Sets is manufactured by Quest Medical, Inc..

What is the FDA product code for Q2 Blood Administration Sets?

The FDA product code for Q2 Blood Administration Sets is FPA.

Related Clinical Trials

NCT07615959 Medicsen Smartpatch: Safety & Performance (SOUNDD) ACTIVE_NOT_RECRUITING NCT06915012 Impact of Biophoton Therapy on Chronic Severe Arthritis Pain RECRUITING NCT07594678 Minoxidil With or Without Low-Level Red-Light Therapy for Improving Chemotherapy-Induced Alopecia in Breast Cancer Patients NOT_YET_RECRUITING NCT07585812 Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia COMPLETED NCT07585227 Study of the Effects of Acute Exposure to Moderate Altitude Hypoxia on Prospective Memory. NOT_YET_RECRUITING NCT03418402 Post Operative Pain After Laparoscopic Hysterectomy Using Airseal® Versus Standard Insufflation System COMPLETED

Related PubMed Literature

PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026)

Other Devices by Quest Medical, Inc.

K162304Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets K162804Q2 Low Pressure Power Injection Extension Set K182442MiniGuard Arterial Safety Valve K173716MPS2 Myocardial Protection System Console K201984MPS 3 ND Myocardial Protection System K200438MPS 3 Myocardial Protection System

View all 10 devices →

Related Devices (Code: FPA)

K160007Paclitaxel SetsBaxter Healthcare Corporation K162304Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension SetsQuest Medical, Inc. K161323Solution Set for Epidural UseBaxter Healthcare Corporation K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc. K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S

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.

↑