Cleared Traditional

K050430 - MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR

K050430 is an FDA 510(k) clearance for MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR, manufactured by Merits Health Products Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K050430 · Merits Health Products Co., Ltd. · Anesthesiology device
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Aug 2005
Decision
167d
Days
Class 2
Risk

K050430 is an FDA 510(k) clearance for the MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR. 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 Co., Ltd. (Fort Myers, US). The FDA issued a Cleared decision on August 4, 2005 after a review of 167 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 Merits Health Products Co., Ltd. devices

FDA 510(k) Submission Details - K050430

510(k) Number K050430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2005
Decision Date August 04, 2005
Days to Decision 167 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
27d slower than avg
Panel avg: 140d · This submission: 167d
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 211
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K050430.
OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615
K052396 · Oxysure Systems, Inc. · Dec 2005
EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR
K043520 · Emg Technology Co., Ltd. · Oct 2005
PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)
K051887 · Carleton Life Support Systems, Inc. · Sep 2005
HOME-AWAY SYSTEM, MODEL 1041
K042944 · In-X Corporation · Apr 2005
MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600
K043006 · Respironics, Inc. · Feb 2005
OXYTEC, MODEL 900
K043615 · Oxytec Medical Corporation · Feb 2005