Cleared Traditional

K233623 - Praxiject™ SP 0.9% NaCl (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233623 · Medxl, Inc. · General Hospital
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Feb 2024
Decision
106d
Days
Class 2
Risk

K233623 is an FDA 510(k) clearance for the Praxiject™ SP 0.9% NaCl. Classified as Saline, Vascular Access Flush (product code NGT), Class II - Special Controls.

Submitted by Medxl, Inc. (Pointe-Claire, CA). The FDA issued a Cleared decision on February 27, 2024 after a review of 106 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Medxl, Inc. devices

Submission Details

510(k) Number K233623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2023
Decision Date February 27, 2024
Days to Decision 106 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 128d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NGT Saline, Vascular Access Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
Definition Enhance The Performance Of Intravascular Catheters, To Maintain Patency Of The Vascular Catheter When It Is Not In Use.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - NGT Saline, Vascular Access Flush

All 40
Devices cleared under the same product code (NGT) and FDA review panel - the closest regulatory comparables to K233623.
0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe
K250884 · Becton, Dickinson and Company · Dec 2025
Flush Syringe (Prefilled 0.9% normal saline solution)
K231724 · Spm Medicare Pvt. , Ltd. · Nov 2023
Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
K231363 · Hantech Medical Device Co., Ltd. · Sep 2023
Pre-Filled Normal Saline Flush Syringe
K223584 · Anhui Tianyang Pharmaceutical Co., Ltd. · Aug 2023
TK Pre-Filled Normal Saline Flush Syringe
K230756 · Anhui Tiankang Medical Technology Co., Ltd. · Aug 2023
0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe
K231161 · Becton, Dickinson and Company · Jul 2023