Cleared Traditional

K910880 - COMFOR-BOARD (FDA 510(k) Clearance)

Class I General Hospital device.

K910880 · Medway · General Hospital
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Jun 1991
Decision
97d
Days
Class 1
Risk

K910880 is an FDA 510(k) clearance for the COMFOR-BOARD. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Medway (Franklin, US). The FDA issued a Cleared decision on June 6, 1991 after a review of 97 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5210 - 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 Medway devices

Submission Details

510(k) Number K910880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1991
Decision Date June 06, 1991
Days to Decision 97 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 128d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMK Device, Intravascular Catheter Securement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5210
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.