Cleared Traditional

K912908 - AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM

K912908 is the FDA 510(k) clearance for AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM by Air-Shields Vickers, Inc.. It is a Class 2 General Hospital device (product code LBI) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K912908 · Air-Shields Vickers, Inc. · General Hospital
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Dec 1991
Decision
164d
Days
Class 2
Risk

K912908 is an FDA 510(k) clearance for the AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Air-Shields Vickers, Inc. (Hatboro, US). The FDA issued a Cleared decision on December 13, 1991 after a review of 164 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5700 - 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 Air-Shields Vickers, Inc. devices

Submission Details

510(k) Number K912908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1991
Decision Date December 13, 1991
Days to Decision 164 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
35d slower than avg
Panel avg: 129d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LBI Unit, Neonatal Phototherapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5700
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 - LBI Unit, Neonatal Phototherapy

All 12
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K912908.
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K894129 · Ohmeda Medical · Sep 1989