Cleared Traditional

K854551 - MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S (FDA 510(k) Clearance)

Class I Anesthesiology device.

K854551 · Medipart Jerry Alexander · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1985
Decision
36d
Days
Class 1
Risk

K854551 is an FDA 510(k) clearance for the MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S. Classified as Nebulizer, Medicinal, Non-ventilatory (atomizer) (product code CCQ), Class I - General Controls.

Submitted by Medipart Jerry Alexander (Cary, US). The FDA issued a Cleared decision on December 19, 1985 after a review of 36 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 Medipart Jerry Alexander devices

Submission Details

510(k) Number K854551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1985
Decision Date December 19, 1985
Days to Decision 36 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 139d · This submission: 36d
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.