Cleared Traditional

Inogen Rove 6 (K230052) - FDA 510(k) Clearance

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

K230052 · Inogen, Inc. · Anesthesiology device
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Jun 2023
Decision
175d
Days
Class 2
Risk

K230052 is an FDA 510(k) clearance for the Inogen Rove 6. 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 Inogen, Inc. (Goleta, US). The FDA issued a Cleared decision on June 30, 2023 after a review of 175 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 Inogen, Inc. devices

Submission Details

510(k) Number K230052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2023
Decision Date June 30, 2023
Days to Decision 175 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
35d slower than avg
Panel avg: 140d · This submission: 175d
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 47
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K230052.
Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
K230702 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Oct 2023
Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)
K223740 · Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd. · Oct 2023
Oxygen concentrator
K222920 · Zhengzhou Olive Electronic Technology Co., Ltd. · Jul 2023
Portable Oxygen Concentrator (Model: P2-E7, P2-E)
K223379 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Jun 2023
Oxus Sieve Beds
K211056 · Oxus, Inc. · May 2023
Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
K213825 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Apr 2023