Cleared Traditional

K922150 - EXAMINATION LAMP

K922150 is an FDA 510(k) clearance for EXAMINATION LAMP, manufactured by Air-Shields, Inc.. The device is a Class 1 General Hospital device with product code KZF cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K922150 · Air-Shields, Inc. · General Hospital
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Jul 1992
Decision
75d
Days
Class 1
Risk

K922150 is an FDA 510(k) clearance for the EXAMINATION LAMP. Classified as Device, Medical Examination, Ac Powered (product code KZF), Class I - General Controls.

Submitted by Air-Shields, Inc. (Hatboro, US). The FDA issued a Cleared decision on July 21, 1992 after a review of 75 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6320 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Air-Shields, Inc. devices

FDA 510(k) Submission Details - K922150

510(k) Number K922150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1992
Decision Date July 21, 1992
Days to Decision 75 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 129d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

KZF Device Classification - Class 1, General Controls

Product Code KZF Device, Medical Examination, Ac Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6320
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.

Regulatory Peers - KZF Device, Medical Examination, Ac Powered

All 11
Devices cleared under the same product code (KZF) and FDA review panel - the closest regulatory comparables to K922150.
AC-POWERED MEDICAL EXAMINATION LIGHT
K934259 · Welch Allyn, Inc. · Jan 1994
RITTER MODEL 158 AND 159 EXAM LIGHTS
K932719 · Midmark Corp. · Dec 1993
LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100
K921493 · Welch Allyn, Inc. · Nov 1992
EPISCOPE, MODEL 47300
K920103 · Welch Allyn, Inc. · Apr 1992
OLYMPIC LIGHT-WARM
K896611 · Olympic Medical Corp. · Feb 1990
TINY HALOGEN EXAM LIGHT
K896962 · Jedmed Instrument Co. · Dec 1989