Cleared Traditional

K160630 - Invacare Platinum Mobile Oxygen Concent...

K160630 is an FDA 510(k) clearance for Invacare Platinum Mobile Oxygen Concent..., manufactured by Invacare Corporation. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K160630 · Invacare Corporation · Anesthesiology device
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Sep 2016
Decision
204d
Days
Class 2
Risk

K160630 is an FDA 510(k) clearance for the Invacare Platinum Mobile 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 Invacare Corporation (Elyria, US). The FDA issued a Cleared decision on September 27, 2016 after a review of 204 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 Invacare Corporation devices

FDA 510(k) Submission Details - K160630

510(k) Number K160630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2016
Decision Date September 27, 2016
Days to Decision 204 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
64d slower than avg
Panel avg: 140d · This submission: 204d
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 120
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K160630.
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SIMPLYGO PORTABLE OXYGEN CONCENTRATOR
K111885 · Respironics, Inc. · Nov 2011
PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150
K103563 · Precision Medical, Inc. · Jul 2011
MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY
K091716 · Merits Health Products Co., Ltd. · Apr 2010