Cleared Traditional

K203210 - Invacare Platinum 5NXG Oxygen Concentrator (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203210 · Invacare Corporation · Anesthesiology device
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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

Submission Details

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
25d slower than avg
Panel avg: 139d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 284
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K203210.
OxyGo Portable Oxygen Concentrator (1400-7000)
K252407 · Mv Life, LLC · Apr 2026
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Oxygen Concentrator (J10A)
K251534 · Foshan Kycare Medical Equipment Co., Ltd. · Dec 2025
Oxygen Concentrator-P2-O5E
K251764 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Dec 2025
Portable oxygen concentrator (JLO-190P)
K252616 · Shenzhen Homed Medical Device Co., Ltd. · Dec 2025
V series portable oxygen concentrator (V5, V5C, V6, V6C)
K252268 · Shenzhen Harveymed Technology Co., Ltd. · Dec 2025