Cleared Traditional

K082689 - STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE (FDA 510(k) Clearance)

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

K082689 · Spectra Medical Devices, Inc. · General Hospital
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Mar 2009
Decision
186d
Days
Class 2
Risk

K082689 is an FDA 510(k) clearance for the STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE. Classified as Saline, Vascular Access Flush (product code NGT), Class II - Special Controls.

Submitted by Spectra Medical Devices, Inc. (Washington, US). The FDA issued a Cleared decision on March 20, 2009 after a review of 186 days - an extended review cycle.

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 Spectra Medical Devices, Inc. devices

Submission Details

510(k) Number K082689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2008
Decision Date March 20, 2009
Days to Decision 186 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 128d · This submission: 186d
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 K082689.
0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe
K250884 · Becton, Dickinson and Company · Dec 2025
Praxiject™ SP 0.9% NaCl
K233623 · Medxl, Inc. · Feb 2024
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