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510(k) K242291

SOL-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 Needle by Sol-Millennium Medical, Inc. — Product Code QNQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2024
Date Received
August 2, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Low Dead Space Piston Syringe
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

A low dead space syringe is a piston syringe designed to reduce medication waste. The device consists of a calibrated hollow barrel, a moveable plunger, and may include a needle. The device can be used by health care professions or for self-injection by the patient.

Other clearances by Sol-Millennium Medical, Inc.

  • K250907 — Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set (April 30, 2025)
  • K242099 — Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Nee (October 22, 2024)
  • K241821 — Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle (September 20, 2024)
  • K220713 — Sol-Guard Auto-disable Syringe (May 4, 2023)
  • K222744 — Sol-M Luer Lock Syringe (October 11, 2022)
  • K213718 — SOL-GUARD Safety Pull Button Collection Set (August 30, 2022)
  • K182146 — Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Ca (December 3, 2018)
  • K163073 — Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder (May 19, 2017)
  • K162030 — 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle (August 19, 2016)
  • K153537 — Sol-M Insulin Syringe, Sol-M TB Syringe (June 17, 2016)

Other clearances for product code QNQ

  • K252814 — Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low (February 19, 2026)
  • K250127 — TSK Syringe (July 30, 2025)
  • K250138 — Small Volume 0.2mL Syringe (April 2, 2025)
  • K232943 — Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe (May 31, 2024)
  • K241190 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volum (May 29, 2024)
  • K231856 — TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) (March 15, 2024)
  • K221860 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volum (September 15, 2023)
  • K213010 — FEELject LDV (Low dead volume) syringe (May 31, 2023)
  • K213013 — Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe (September 19, 2022)
  • K220083 — LDV((Low Dead Volume )Syringe (May 25, 2022)