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)

Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)

K-Number: K251676 · 2025-09-16

ApplicantMicrotek Medical, LLC
Decision Date2025-09-16
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) is a medical device manufactured by Microtek Medical, LLC. It received FDA 510(k) clearance on 2025-09-16 under approval number K251676. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)?

Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) is a medical device that received FDA 510(k) clearance on 2025-09-16. It is manufactured by Microtek Medical, LLC. The 510(k) number is K251676.

When was Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) approved by the FDA?

Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) received FDA 510(k) clearance on 2025-09-16, under approval number K251676.

What company makes Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)?

Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) is manufactured by Microtek Medical, LLC.

What is the FDA product code for Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)?

The FDA product code for Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) is LHI.

Related Clinical Trials

NCT07592533 A Single Arm Study of Extracorporeal Shockwave Therapy for Management of Erectile Dysfunction RECRUITING NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING NCT07384741 Using Virtual Reality During PICC and PICC-PORT Placement in Cancer Patients ACTIVE_NOT_RECRUITING NCT07529444 Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants RECRUITING NCT07396181 Standardization of Variable Conditions of Embryo Transfer Into the Uterine Cavity in the Procedure of Medically Assisted Procreation in Humans RECRUITING NCT06866197 CONNECT: A Multi-Cohort, Prospective Investigation of the Symani® Surgical System RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025) PMID: 40549731 Assessment of digital therapeutics in decentralized clinical trials: A scoping review. PLOS digital health (2025)

Related Devices (Code: LHI)

K161800OnSite-IVPharmc, LLC K160503Vented Vial Adapter Transfer Device - 13mmMedimop Medical Projects, Ltd. K151423APEX Compounding System Transfer SetB.Braun Medical, Inc. K162216GRI-FILL PERISTALTIC SETLaboratorios Grifols, S.A. K171796Vial Adapter 15mmMedimop Medical Project , Ltd. K172884Arisure Closed Vial AdapterYukon Medical

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.

↑