Cleared Traditional

K132778 - GRAB 'N GO PLUS, GRAB 'N GO DIGITAL (FDA 510(k) Clearance)

Class I Anesthesiology device.

K132778 · Praxair Healthcare Services · Anesthesiology device
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Jul 2014
Decision
305d
Days
Class 1
Risk

K132778 is an FDA 510(k) clearance for the GRAB 'N GO PLUS, GRAB 'N GO DIGITAL. Classified as Cylinder, Compressed Gas, And Valve (product code ECX), Class I - General Controls.

Submitted by Praxair Healthcare Services (Marlborough, US). The FDA issued a Cleared decision on July 7, 2014 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2700 - 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. Elevated predicate reliance profile. 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 K132778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2013
Decision Date July 07, 2014
Days to Decision 305 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
166d slower than avg
Panel avg: 139d · This submission: 305d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ECX Cylinder, Compressed Gas, And Valve
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2700
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.