Cleared Abbreviated

K051800 - IN6 SAFETY SYRINGE, MODEL 3ML

K051800 is an FDA 510(k) clearance for IN6 SAFETY SYRINGE, manufactured by In6 Incuvestor, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Abbreviated 510(k) pathway after a 108-day FDA review.

K051800 · In6 Incuvestor, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K051800

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 129d · This submission: 108d
Pathway characteristics
Standards-based clearance path.

MEG Device Classification - Class 2, Special Controls

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 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K051800.
CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,
K060208 · Life-Shield Products, Inc. · Mar 2006
CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML)
K052397 · Life-Shield Products, Inc. · Dec 2005
CLICKZIP NEEDLE RETRACTABLE SAFETY SYRINGE
K051694 · Medical Device Manufacturer (Thailand) , Ltd. · Dec 2005
EXEL SECURE TOUCH II SAFETY SYRINGE
K052103 · Exelint Intl. Co. · Oct 2005
TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR
K051865 · Terumo Medical Corp. · Sep 2005
SAF-T-SYRINGE/SAF-T-NEEDLE
K051762 · Safety Medical International, Incorporated · Sep 2005
K051800 · IN6 SAFETY SYRINGE, MODEL 3ML
Download PDF FDA Summary In6 Incuvestor, Inc.