Cleared Traditional

K902141 - ANOLIFT - PORTABLE & ANOLIFT - GANTRY

K902141 is an FDA 510(k) clearance for ANOLIFT - PORTABLE & ANOLIFT - GANTRY, manufactured by Anodyne Corp.. The device is a Class 1 General Hospital device with product code FSA cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K902141 · Anodyne Corp. · General Hospital
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Sep 1990
Decision
120d
Days
Class 1
Risk

K902141 is an FDA 510(k) clearance for the ANOLIFT - PORTABLE & ANOLIFT - GANTRY. Classified as Lift, Patient, Non-ac-powered (product code FSA), Class I - General Controls.

Submitted by Anodyne Corp. (Brighton, US). The FDA issued a Cleared decision on September 12, 1990 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 880.5510 - 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 Anodyne Corp. devices

FDA 510(k) Submission Details - K902141

510(k) Number K902141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1990
Decision Date September 12, 1990
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.

FSA Device Classification - Class 1, General Controls

Product Code FSA Lift, Patient, Non-ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5510
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.