Cleared Traditional

K230756 - TK Pre-Filled Normal Saline Flush Syringe (FDA 510(k) Clearance)

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

K230756 · Anhui Tiankang Medical Technology Co., Ltd. · General Hospital
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Aug 2023
Decision
145d
Days
Class 2
Risk

K230756 is an FDA 510(k) clearance for the TK Pre-Filled Normal Saline Flush Syringe. Classified as Saline, Vascular Access Flush (product code NGT), Class II - Special Controls.

Submitted by Anhui Tiankang Medical Technology Co., Ltd. (Tianchang, CN). The FDA issued a Cleared decision on August 12, 2023 after a review of 145 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 Anhui Tiankang Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K230756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2023
Decision Date August 12, 2023
Days to Decision 145 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 128d · This submission: 145d
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 Consultant

Share Info (Guangzhou) Medical Consultant , Ltd.
Cassie Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K230756.
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
0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe
K231161 · Becton, Dickinson and Company · Jul 2023