Cleared Traditional

K192693 - Nuvo Nano Portable Oxygen Concentrator

K192693 is the FDA 510(k) clearance for Nuvo Nano Portable Oxygen Concentrator by Nidek Medical Products, Inc.. It is a Class 2 Anesthesiology device (product code CAW) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K192693 · Nidek Medical Products, Inc. · Anesthesiology device
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May 2020
Decision
224d
Days
Class 2
Risk

K192693 is an FDA 510(k) clearance for the Nuvo Nano Portable 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 Nidek Medical Products, Inc. (Birmingham, US). The FDA issued a Cleared decision on May 7, 2020 after a review of 224 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 Nidek Medical Products, Inc. devices

Submission Details

510(k) Number K192693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2019
Decision Date May 07, 2020
Days to Decision 224 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
84d slower than avg
Panel avg: 140d · This submission: 224d
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 76
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K192693.
Invacare Perfecto2V Oxygen Concentrator
K200890 · Invacare Corporation · Aug 2020
Aer X
K200496 · 3B Medical, Inc. · Jul 2020
Owgels Oxygen Concentrator
K191875 · Guangzhou Life Light Electronic Technology Co., Ltd. · Jul 2020
Kingon P2 Oxygen Concentrator
K190304 · Qingdao Kingon Medical Science and Technology Co. · Feb 2020
Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity
K191159 · Invacare Corporation · Aug 2019
CONTEC Oxygen Concentrator
K180837 · Contec Medical System Co., Ltd. · Jan 2019