Cleared Traditional

K912908 - AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM

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

K912908 · Air-Shields Vickers, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K912908

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.

LBI Device Classification - Class 2, Special Controls

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 51
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K912908.
DRAGER PT4000 PHOTOTHERAPY SYSTEM
K954611 · Drager, Inc. · Dec 1995
OLYMPIC BILI-LITE
K940996 · Olympic Medical Corp. · Sep 1994
BILIBLANKET LIGHT METER
K910571 · Ohmeda Medical · Jul 1992
OLYMPIC BILI-METER(TM) WITH TYPE-F SENSOR
K903445 · Olympic Medical Corp. · Oct 1990
OLYMPIC MINI BILI-LITE, MODEL 77
K902749 · Olympic Medical Corp. · Aug 1990
OLYMPIC BILI-LITE-PAD(TM)
K901987 · Olympic Medical Corp. · Jul 1990