Cleared Traditional

K072469 - DIGIFLO CONCENTRATOR ANALYZER

K072469 is an FDA 510(k) clearance for DIGIFLO CONCENTRATOR ANALYZER, manufactured by Digiflo, Inc.. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K072469 · Digiflo, Inc. · Anesthesiology device
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Jan 2008
Decision
121d
Days
Class 2
Risk

K072469 is an FDA 510(k) clearance for the DIGIFLO CONCENTRATOR ANALYZER. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Digiflo, Inc. (Mercer Island, US). The FDA issued a Cleared decision on January 3, 2008 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1720 - 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.

View all Digiflo, Inc. devices

FDA 510(k) Submission Details - K072469

510(k) Number K072469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2007
Decision Date January 03, 2008
Days to Decision 121 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
19d faster than avg
Panel avg: 140d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCL Device Classification - Class 2, Special Controls

Product Code CCL Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CCL Analyzer, Gas, Oxygen, Gaseous-phase

All 50
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