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510(k) K213522

AMSafe Pre-Filled Normal Saline Flush Syringe by Amsino International, Inc. — Product Code NGT

K213522 is an FDA 510(k) premarket notification submitted by Amsino International, Inc. for the device "AMSafe Pre-Filled Normal Saline Flush Syringe". The FDA issued a decision of Substantially Equivalent on March 22, 2022. The device falls under product code NGT (Saline, Vascular Access Flush), a Class II device regulated under 21 CFR 880.5200. Amsino International, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2022
Date Received
November 3, 2021
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 Amsino International, Inc.

  • K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, (May 4, 2026)
  • K220230 — AMSure Enteral Feeding Pump (November 10, 2022)
  • K220267 — AMSafe NeuFlo Needleless Connector (October 7, 2022)
  • K200051 — PUGGLE Enteral Feeding Pump and Feeding Set (September 25, 2020)
  • K183473 — AMSafe(R) Pre-Filled Normal Saline Flush Syringe (July 12, 2019)
  • K181445 — AMSure Hydrophilic Intermittent Catheter (October 1, 2018)
  • K181423 — AMSure Sterile Water, and Sterile Normal Saline for Wound Flush (September 7, 2018)
  • K173665 — AMSafe Sure-Lok Needle-Free Connector (September 5, 2018)
  • K181814 — AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water (September 4, 2018)
  • K171857 — AMSure® Enteral Feeding Syringe with ENFit Tip (March 30, 2018)

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)
  • K223584 — Pre-Filled Normal Saline Flush Syringe (August 12, 2023)
  • K230756 — TK 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)
  • K201286 — 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0 (August 11, 2020)

FDA data resources