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510(k) K163073

Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder by Sol-Millennium Medical, Inc. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2017
Date Received
November 2, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Sol-Millennium Medical, Inc.

  • K250907 — Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set (April 30, 2025)
  • K242291 — SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low (November 20, 2024)
  • 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)
  • 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 JKA

  • K252040 — BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Bloo (March 13, 2026)
  • K251812 — Steripath® Flow™ Blood Collection System (September 25, 2025)
  • K243207 — BD Vacutainer® Eclipse™ Blood Collection Needle (July 3, 2025)
  • K250961 — Blood collection tube holders (June 4, 2025)
  • K244047 — Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) (May 23, 2025)
  • K250907 — Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set (April 30, 2025)
  • K243649 — BD Vacutainer® Multiple Sample Luer Adapter (March 21, 2025)
  • K241586 — PIVO™ Pro Needle-free Blood Collection Device (February 27, 2025)
  • K242320 — BD Vacutainer® One Use Holder (November 1, 2024)
  • K233979 — VACUETTE® QUICKSHIELD Complete (Plus) (July 19, 2024)