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)

Small Volume 0.2mL Syringe

K-Number: K250138 · 2025-04-02

ApplicantProsum Medical Limited
Decision Date2025-04-02
Product CodeQNQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Small Volume 0.2mL Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Prosum Medical Limited. It received FDA 510(k) clearance on 2025-04-02 under 510(k) number K250138. The device is classified under product code QNQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Small Volume 0.2mL Syringe?

Small Volume 0.2mL Syringe is a medical device that received FDA 510(k) clearance on 2025-04-02. The listed applicant is Prosum Medical Limited. The 510(k) number is K250138.

When did Small Volume 0.2mL Syringe receive FDA 510(k) clearance?

Small Volume 0.2mL Syringe received FDA 510(k) clearance on 2025-04-02, under 510(k) number K250138.

Who is the listed applicant for Small Volume 0.2mL Syringe?

The FDA 510(k) record lists Prosum Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Small Volume 0.2mL Syringe?

The FDA product code for Small Volume 0.2mL Syringe is QNQ.

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.

NCT05975372Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast ReconstructionRECRUITING

Related Devices (Code: QNQ)

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.

K252814Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety SyringeCMT Health PTE., Ltd.K250127TSK SyringeTsk Laboratory, JapanK242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable NeedleSol-Millennium Medical, Inc.K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc.K241190PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile SyringePoonglim Pharmatech, Inc.K231856TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))Medexel Co.,Ltd

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.

↑