Cleared Traditional

K231888 - BD Texium™ Needle-Free Syringe

K231888 is an FDA 510(k) clearance for BD Texium Needle-Free Syringe, manufactured by Care Fusion. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K231888

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
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

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 480
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K231888.
EpiZact
K233056 · Guidestar Medical Devices · Nov 2023
Disposable Sterile Syringe
K221777 · Weihai Shengjie Medical Technology Co., Ltd. · Oct 2023
VeriSafe Safety sterile syringes
K231792 · Promisemed Hangzhou Meditech Co., Ltd. · Sep 2023
Sterile Auto-Disable Syringes with/without Needle for Single Use
K231727 · Wepon Medical Technology Co., Ltd. · Sep 2023
A-TAP (previously called Arthrotap)
K231900 · Elcam Medical Acal · Jul 2023
Hypodermic Syringes & Needle
K222925 · Lifelong Meditech Private Limited · Jul 2023