Cleared Traditional

K113853 - G+ SYSTEM

K113853 is an FDA 510(k) clearance for G+ SYSTEM, manufactured by Glytec, LLC. The device is a Class 2 General Hospital device with product code NDC cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K113853 · Glytec, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
131d
Days
Class 2
Risk

K113853 is an FDA 510(k) clearance for the G+ SYSTEM. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Glytec, LLC (Greenville, US). The FDA issued a Cleared decision on May 8, 2012 after a review of 131 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.1890 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Glytec, LLC devices

FDA 510(k) Submission Details - K113853

510(k) Number K113853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2011
Decision Date May 08, 2012
Days to Decision 131 days
Submission Type Traditional
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
2d slower than avg
Panel avg: 129d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDC Device Classification - Class 2, Special Controls

Product Code NDC Calculator, Drug Dose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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 - NDC Calculator, Drug Dose

All 42
Devices cleared under the same product code (NDC) and FDA review panel - the closest regulatory comparables to K113853.
GLUCOSTABILIZER INSULIN DOSING CALCULATOR
K141321 · Medical Decision Network · Sep 2014
ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)
K132547 · Monarch Medical Technologies · Apr 2014
PICIS WEIGHT BASED DOSE CONVERTER
K121542 · Picis, Inc. · Aug 2012
ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
K043529 · Roche Diagnostics Corp. · Apr 2005
ABBOTT PHARAMACOKINETICS SYSTEMS
K851573 · Abbott Laboratories · Jan 1986