Cleared Traditional

K182268 - EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) (FDA 510(k) Clearance)

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

K182268 · Flat Medical Co., Ltd. · General Hospital
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Apr 2019
Decision
227d
Days
Class 2
Risk

K182268 is an FDA 510(k) clearance for the EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit). Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Flat Medical Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on April 5, 2019 after a review of 227 days - an extended review cycle.

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 Flat Medical Co., Ltd. devices

Submission Details

510(k) Number K182268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2018
Decision Date April 05, 2019
Days to Decision 227 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
99d slower than avg
Panel avg: 128d · This submission: 227d
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
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