Cleared Traditional

K852527 - SATALEC SEPTOSONIC SC 80/SC 120

K852527 is an FDA 510(k) clearance for SATALEC SEPTOSONIC SC 80/SC 120, manufactured by Spelna, Inc.. The device is a Class 1 General Hospital device with product code FLG cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K852527 · Spelna, Inc. · General Hospital
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Jan 1986
Decision
203d
Days
Class 1
Risk

K852527 is an FDA 510(k) clearance for the SATALEC SEPTOSONIC SC 80/SC 120. Classified as Cleaner, Ultrasonic, Medical Instrument (product code FLG), Class I - General Controls.

Submitted by Spelna, Inc. (Fredericksburg, US). The FDA issued a Cleared decision on January 3, 1986 after a review of 203 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6150 - 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 Spelna, Inc. devices

FDA 510(k) Submission Details - K852527

510(k) Number K852527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1985
Decision Date January 03, 1986
Days to Decision 203 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
74d slower than avg
Panel avg: 129d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

FLG Device Classification - Class 1, General Controls

Product Code FLG Cleaner, Ultrasonic, Medical Instrument
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6150
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.