Cleared Traditional

K203210 - Invacare Platinum 5NXG Oxygen Concentrator

K203210 is an FDA 510(k) clearance for Invacare Platinum 5NXG Oxygen Concentrator, manufactured by Invacare Corporation. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K203210 · Invacare Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
164d
Days
Class 2
Risk

K203210 is an FDA 510(k) clearance for the Invacare Platinum 5NXG 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 Invacare Corporation (Elyria, US). The FDA issued a Cleared decision on April 12, 2021 after a review of 164 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 Invacare Corporation devices

FDA 510(k) Submission Details - K203210

510(k) Number K203210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2020
Decision Date April 12, 2021
Days to Decision 164 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
24d slower than avg
Panel avg: 140d · This submission: 164d
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 170
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K203210.
Oxygen Concentrator, Model JAY-5AW
K213210 · Longfian Scitech Co., Ltd. · Dec 2022
Portable Oxygen Concentrator, model: P2-E6
K210371 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Jun 2022
Oxygen Concentrator
K202389 · Foshan Mic Medical Technology Co., Ltd. · Apr 2022
X-PLO2R
K203086 · Belluscura, LLC · Mar 2021
Invacare Perfecto2V Oxygen Concentrator
K200890 · Invacare Corporation · Aug 2020
Aer X
K200496 · 3B Medical, Inc. · Jul 2020