Cleared Traditional

K112789 - EASY TOUCH

K112789 is an FDA 510(k) clearance for EASY TOUCH, manufactured by Mhc Medical Products, LLC. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K112789 · Mhc Medical Products, LLC · General Hospital
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Dec 2011
Decision
88d
Days
Class 2
Risk

K112789 is an FDA 510(k) clearance for the EASY TOUCH. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Mhc Medical Products, LLC (Naples, US). The FDA issued a Cleared decision on December 23, 2011 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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: 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 Mhc Medical Products, LLC devices

FDA 510(k) Submission Details - K112789

510(k) Number K112789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2011
Decision Date December 23, 2011
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 305
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