Cleared Traditional

K051860 - FLEXIBLE INTRODUCER CANNULA

K051860 is the FDA 510(k) clearance for FLEXIBLE INTRODUCER CANNULA by Epimed International, Inc.. It is a Class 2 Anesthesiology device (product code MIA) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K051860 · Epimed International, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Aug 2005
Decision
45d
Days
Class 2
Risk

K051860 is an FDA 510(k) clearance for the FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837. Classified as Needle, Spinal, Short Term (product code MIA), Class II - Special Controls.

Submitted by Epimed International, Inc. (Johnstown, US). The FDA issued a Cleared decision on August 22, 2005 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5150 - the FDA anesthesiology and respiratory 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Epimed International, Inc. devices

Submission Details

510(k) Number K051860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2005
Decision Date August 22, 2005
Days to Decision 45 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 140d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MIA Needle, Spinal, Short Term
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5150
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 - MIA Needle, Spinal, Short Term

Devices cleared under the same product code (MIA) and FDA review panel - the closest regulatory comparables to K051860.
Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors
K172800 · Smiths Medical Asd, Inc. · Jun 2018
CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA
K982269 · Allegiance Healthcare Corp. · Jul 1998
ACUFEX T-FIX DELIVERY SYSTEM
K942442 · Acufex Microsurgical, Inc. · Dec 1994