Cleared Traditional

K853350 - SYNCHRONER TM (PROPOSED TRADENAME) (FDA 510(k) Clearance)

Class I Anesthesiology device.

K853350 · Fisons Corp. · Anesthesiology device
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Aug 1985
Decision
17d
Days
Class 1
Risk

K853350 is an FDA 510(k) clearance for the SYNCHRONER TM (PROPOSED TRADENAME). Classified as Nebulizer, Medicinal, Non-ventilatory (atomizer) (product code CCQ), Class I - General Controls.

Submitted by Fisons Corp. (Bedford, US). The FDA issued a Cleared decision on August 29, 1985 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5640 - 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 Fisons Corp. devices

Submission Details

510(k) Number K853350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date August 29, 1985
Days to Decision 17 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 139d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CCQ Nebulizer, Medicinal, Non-ventilatory (atomizer)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5640
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.