Cleared Abbreviated

IN6 SAFETY SYRINGE, MODEL 3ML (K051800) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K051800 · In6 Incuvestor, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 2005
Decision
108d
Days
Class 2
Risk

K051800 is an FDA 510(k) clearance for the IN6 SAFETY SYRINGE, MODEL 3ML. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by In6 Incuvestor, Inc. (Flagstaff, US). The FDA issued a Cleared decision on October 21, 2005 after a review of 108 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all In6 Incuvestor, Inc. devices

Submission Details

510(k) Number K051800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2005
Decision Date October 21, 2005
Days to Decision 108 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 129d · This submission: 108d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MEG Syringe, Antistick
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 - MEG Syringe, Antistick

All 37
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K051800.
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K936040 · Smith & Nephew, Inc. · May 1995