Cleared Traditional

Nuvo Nano Portable Oxygen Concentrator (K192693) - FDA 510(k) Clearance

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

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
85d slower than avg
Panel avg: 139d · 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 285
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K192693.
Oxygen Concentrator (OX-5A, OX-5C)
K252965 · Oxytek Medical Technology Co., Ltd. · May 2026
OxyGo Portable Oxygen Concentrator (1400-7000)
K252407 · Mv Life, LLC · Apr 2026
DeVilbiss 5 Liter Oxygen Concentrator (555)
K253549 · Devilbiss Healthcare, LLC · Mar 2026
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