Cleared Traditional

INSULIN PROTECTOR (K073555) - FDA 510(k) Clearance

Class I General Hospital device.

K073555 · Medicool, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
206d
Days
Class 1
Risk

K073555 is an FDA 510(k) clearance for the INSULIN PROTECTOR. Classified as Adaptor, Holder, Syringe (product code IQG), Class I - General Controls.

Submitted by Medicool, Inc. (Torrance, US). The FDA issued a Cleared decision on July 11, 2008 after a review of 206 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 890.5050 - 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 Medicool, Inc. devices

Submission Details

510(k) Number K073555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2007
Decision Date July 11, 2008
Days to Decision 206 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
77d slower than avg
Panel avg: 129d · This submission: 206d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IQG Adaptor, Holder, Syringe
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5050
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.