Cleared Traditional

K230052 - Inogen Rove 6

K230052 is an FDA 510(k) clearance for Inogen Rove 6, manufactured by Inogen, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 175-day FDA review.

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

FDA 510(k) Submission Details - K230052

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.

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 91
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K230052.
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Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
K213825 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Apr 2023