Cleared Traditional

GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM (K081388) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081388 · Pronia Medical System, LLC · General Hospital
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Aug 2008
Decision
94d
Days
Class 2
Risk

K081388 is an FDA 510(k) clearance for the GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Pronia Medical System, LLC (North Attleboro, US). The FDA issued a Cleared decision on August 21, 2008 after a review of 94 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 Pronia Medical System, LLC devices

Submission Details

510(k) Number K081388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2008
Decision Date August 21, 2008
Days to Decision 94 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
35d faster than avg
Panel avg: 129d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.