Cleared Traditional

K951882 - ECO CHECK (ECOVALVE AND OXYGEN MONITOR)

K951882 is an FDA 510(k) clearance for ECO CHECK (ECOVALVE AND OXYGEN MONITOR), manufactured by Airsep Corp.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K951882 · Airsep Corp. · Anesthesiology device
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Oct 1995
Decision
196d
Days
Class 2
Risk

K951882 is an FDA 510(k) clearance for the ECO CHECK (ECOVALVE AND OXYGEN MONITOR). Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Airsep Corp. (Buffalo, US). The FDA issued a Cleared decision on October 16, 1995 after a review of 196 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - 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 Airsep Corp. devices

FDA 510(k) Submission Details - K951882

510(k) Number K951882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1995
Decision Date October 16, 1995
Days to Decision 196 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 140d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAW Device Classification - Class 2, Special Controls

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
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 - CAW Generator, Oxygen, Portable

All 92
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K951882.
PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI
K993088 · Puritan Bennett Corp. · Oct 1999
MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM
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5 LPM OXYGEN CONCENTRATOR
K953815 · Devilbiss Health Care, Inc. · Nov 1995
3 LPM OXYGEN CONCENTRATOR
K952037 · Devilbiss Health Care, Inc. · Sep 1995
H-500 ALLIANCE OXYGEN CONCENTRATOR
K942357 · Healthdyne, Inc. · May 1994
MOBILAIRE V & III PRO2 OXYGEN SENSORS FEATURES
K924818 · Invacare Corp. · Aug 1993