Home / 510(k) Clearances / K191378

510(k) K191378

0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe by Medline Industries, Inc. — Product Code NGT

K191378 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe". The FDA issued a decision of Substantially Equivalent on September 15, 2019. The device falls under product code NGT (Saline, Vascular Access Flush), a Class II device regulated under 21 CFR 880.5200. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2019
Date Received
May 23, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saline, Vascular Access Flush
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.

Other clearances by Medline Industries, Inc.

  • K253526 — NAMIC Dilator and Sheath (July 29, 2026)
  • K254287 — Medline Reusable Blood Pressure Cuff (June 22, 2026)
  • K253322 — Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” I (March 25, 2026)
  • K251687 — Konig Bell Circumcision Clamp (February 25, 2026)
  • K253070 — Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRA (November 20, 2025)
  • K250345 — Medline Bag Decanter (October 24, 2025)
  • K250312 — Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo (July 2, 2025)
  • K243888 — Medline UNITE® REFLEX® Hybrid Nitinol Implant System (April 11, 2025)
  • K242844 — Medline Level 4 Surgical Gown with Breathable Sleeves (February 26, 2025)
  • K242370 — Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection (December 19, 2024)

Other clearances for product code NGT

  • K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (December 2, 2025)
  • K233623 — Praxiject™ SP 0.9% NaCl (February 27, 2024)
  • K231724 — Flush Syringe (Prefilled 0.9% normal saline solution) (November 9, 2023)
  • K231363 — Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, (September 27, 2023)
  • K230756 — TK Pre-Filled Normal Saline Flush Syringe (August 12, 2023)
  • K223584 — Pre-Filled Normal Saline Flush Syringe (August 12, 2023)
  • K231161 — 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe (July 21, 2023)
  • K231754 — Praxiject™ 0.9% NaCl (July 13, 2023)
  • K214080 — Pentaflush (July 20, 2022)
  • K213522 — AMSafe Pre-Filled Normal Saline Flush Syringe (March 22, 2022)

FDA data resources