Cleared Traditional

K864822 - VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS (FDA 510(k) Clearance)

Class I Anesthesiology device.

K864822 · Surgidyne, Inc. · Anesthesiology device
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Jan 1987
Decision
37d
Days
Class 1
Risk

K864822 is an FDA 510(k) clearance for the VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS. Classified as Bag, Reservoir (product code BTC), Class I - General Controls.

Submitted by Surgidyne, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on January 15, 1987 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5320 - the FDA anesthesiology and respiratory 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 Surgidyne, Inc. devices

Submission Details

510(k) Number K864822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1986
Decision Date January 15, 1987
Days to Decision 37 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 139d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BTC Bag, Reservoir
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5320
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.