Cleared Traditional

K915303 - FOIL BABY BUNTING (FDA 510(k) Clearance)

Class I General Hospital device.

K915303 · Gam Industries, Inc. · General Hospital
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Feb 1992
Decision
91d
Days
Class 1
Risk

K915303 is an FDA 510(k) clearance for the FOIL BABY BUNTING. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by Gam Industries, Inc. (Petersburg, US). The FDA issued a Cleared decision on February 20, 1992 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6060 - 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 Gam Industries, Inc. devices

Submission Details

510(k) Number K915303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1991
Decision Date February 20, 1992
Days to Decision 91 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 128d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KME Bedding, Disposable, Medical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6060
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.