Cleared Special

EpiFaith Syringe (K192421) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K192421 · Flat Medical Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
23d
Days
Class 2
Risk

K192421 is an FDA 510(k) clearance for the EpiFaith Syringe. 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 September 27, 2019 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 880.5860 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Flat Medical Co., Ltd. devices

Submission Details

510(k) Number K192421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2019
Decision Date September 27, 2019
Days to Decision 23 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 140d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 Anesthesiology devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 240
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K192421.
BD Insulin Syringe
K190054 · Becton, Dickinson and Company · Oct 2019
Instylla Delivery Kit
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Nipro Syringe
K191359 · Nipro Medical Corporation · Oct 2019
Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use
K190002 · Shanghai Kohope Medical Devices Co., Ltd. · Sep 2019
Sure-Fine Insulin Syringes
K191531 · Shina Med Corporation · Sep 2019
5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe
K182765 · Top Corporation · Sep 2019