Cleared Traditional

K941869 - SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG

K941869 is an FDA 510(k) clearance for SPLINT, manufactured by The Lighthouse For the Blind, Inc.. The device is a Class 1 General Hospital device with product code KZF cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K941869 · The Lighthouse For the Blind, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
107d
Days
Class 1
Risk

K941869 is an FDA 510(k) clearance for the SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG. Classified as Device, Medical Examination, Ac Powered (product code KZF), Class I - General Controls.

Submitted by The Lighthouse For the Blind, Inc. (Seattle, US). The FDA issued a Cleared decision on August 3, 1994 after a review of 107 days - within the typical 510(k) review window.

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: 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 The Lighthouse For the Blind, Inc. devices

FDA 510(k) Submission Details - K941869

510(k) Number K941869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1994
Decision Date August 03, 1994
Days to Decision 107 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 129d · This submission: 107d
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 15
Devices cleared under the same product code (KZF) and FDA review panel - the closest regulatory comparables to K941869.
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CHROMOPHARE
K935832 · Berchtold Holding GmbH · Feb 1994
AC-POWERED MEDICAL EXAMINATION LIGHT
K934259 · Welch Allyn, Inc. · Jan 1994