Cleared Traditional

K852943 - NEO SHIELD

K852943 is the FDA 510(k) clearance for NEO SHIELD by Gaymar Industries, Inc.. It is a Class 2 General Hospital device (product code FMT) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K852943 · Gaymar Industries, Inc. · General Hospital
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Nov 1985
Decision
120d
Days
Class 2
Risk

K852943 is an FDA 510(k) clearance for the NEO SHIELD. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Gaymar Industries, Inc. (Orchard Park, US). The FDA issued a Cleared decision on November 8, 1985 after a review of 120 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5130 - 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 Gaymar Industries, Inc. devices

Submission Details

510(k) Number K852943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1985
Decision Date November 08, 1985
Days to Decision 120 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
9d faster than avg
Panel avg: 129d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMT Warmer, Infant Radiant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5130
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 - FMT Warmer, Infant Radiant

All 24
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K852943.
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INFANT WARMER
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