Cleared Traditional

K191159 - Concentrator with Single battery pack

K191159 is the FDA 510(k) clearance for Concentrator with Single battery pack by Invacare Corporation. It is a Class 2 Anesthesiology device (product code CAW) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K191159 · Invacare Corporation · Anesthesiology device
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Aug 2019
Decision
120d
Days
Class 2
Risk

K191159 is an FDA 510(k) clearance for the Concentrator with Single battery pack, carry bag with shoulder strap, back pa.... 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 August 29, 2019 after a review of 120 days - within the typical 510(k) review window.

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 K191159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2019
Decision Date August 29, 2019
Days to Decision 120 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
20d faster than avg
Panel avg: 140d · This submission: 120d
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 75
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K191159.
Owgels Oxygen Concentrator
K191875 · Guangzhou Life Light Electronic Technology Co., Ltd. · Jul 2020
Nuvo Nano Portable Oxygen Concentrator
K192693 · Nidek Medical Products, Inc. · May 2020
Kingon P2 Oxygen Concentrator
K190304 · Qingdao Kingon Medical Science and Technology Co. · Feb 2020
CONTEC Oxygen Concentrator
K180837 · Contec Medical System Co., Ltd. · Jan 2019
O2 Concepts Oxlife Independence Model 301-0001
K182454 · O2 Concepts, LLC · Dec 2018
Oxygen Concentrator
K172234 · Sysmed (China) Co., Ltd. · Jun 2018