Cleared Traditional

K231888 - BD Texium™ Needle-Free Syringe (FDA 510(k) Clearance)

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

K231888 · Care Fusion · General Hospital
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Sep 2023
Decision
90d
Days
Class 2
Risk

K231888 is an FDA 510(k) clearance for the BD Texium™ Needle-Free Syringe. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Care Fusion (San Diego, US). The FDA issued a Cleared decision on September 25, 2023 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Care Fusion devices

Submission Details

510(k) Number K231888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2023
Decision Date September 25, 2023
Days to Decision 90 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
38d faster than avg
Panel avg: 128d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 748
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K231888.
Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)
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EXEL Disposable Syringe
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K250192 · Promisemed Hangzhou Meditech Co., Ltd. · Dec 2025