Cleared Traditional

VITASAN (K821259) - FDA 510(k) Clearance

Class I General Hospital device.

K821259 · Selomas, Inc. · General Hospital
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Jun 1982
Decision
54d
Days
Class 1
Risk

K821259 is an FDA 510(k) clearance for the VITASAN. Classified as Stocking, Medical Support (for General Medical Purposes) (product code FQL), Class I - General Controls.

Submitted by Selomas, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 23, 1982 after a review of 54 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5780 - 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 Selomas, Inc. devices

Submission Details

510(k) Number K821259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1982
Decision Date June 23, 1982
Days to Decision 54 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
75d faster than avg
Panel avg: 129d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FQL Stocking, Medical Support (for General Medical Purposes)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5780
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.