Cleared Traditional

K011844 - MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS

K011844 is an FDA 510(k) clearance for MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS, manufactured by Merits Health Products., Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K011844 · Merits Health Products., Inc. · Anesthesiology device
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Aug 2001
Decision
77d
Days
Class 2
Risk

K011844 is an FDA 510(k) clearance for the MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS. 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 Merits Health Products., Inc. (Fort Myers, US). The FDA issued a Cleared decision on August 28, 2001 after a review of 77 days - a notably fast clearance 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: 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 Merits Health Products., Inc. devices

FDA 510(k) Submission Details - K011844

510(k) Number K011844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2001
Decision Date August 28, 2001
Days to Decision 77 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 140d · This submission: 77d
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 215
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K011844.
ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM
K014078 · On Site Gas Systems, Inc. · Jan 2002
HOME-AWAY SYSTEM
K004047 · In-X Corp. · Dec 2001
TOTAL O2
K013472 · Chad Therapeutics, Inc. · Nov 2001
INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM
K003472 · Sequal Technologies, Inc. · Jun 2001
VENTURE HOME FILL II, MODEL IOH 200
K003939 · Invacare Corp. · Mar 2001
DEVILBISS 5 LITER OXYGEN CONCENTRATOR
K991722 · Sunrise Medical Hhg, Inc. · Nov 1999