Cleared Traditional

K121661 - EZ-ASSIST-FILL (FDA 510(k) Clearance)

Class I Anesthesiology device.

K121661 · Assist Fill, LLC · Anesthesiology device
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Dec 2012
Decision
205d
Days
Class 1
Risk

K121661 is an FDA 510(k) clearance for the EZ-ASSIST-FILL. Classified as Portable Liquid Oxygen Unit Stand (product code PCM), Class I - General Controls.

Submitted by Assist Fill, LLC (Great Neck, US). The FDA issued a Cleared decision on December 27, 2012 after a review of 205 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 890.5050 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K121661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2012
Decision Date December 27, 2012
Days to Decision 205 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 139d · This submission: 205d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PCM Portable Liquid Oxygen Unit Stand
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5050
Definition To Assist The User With Refilling A Portable Liquid Oxygen Tank From A Reservoir Unit By Holding The Portable Liquid Oxygen Tank In An Upright Position.
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.