Cleared Traditional

K103563 - PRECISION PORTABLE OXYGEN CONCENTRATION...

K103563 is an FDA 510(k) clearance for PRECISION PORTABLE OXYGEN CONCENTRATION..., manufactured by Precision Medical, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K103563 · Precision Medical, Inc. · Anesthesiology device
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Jul 2011
Decision
207d
Days
Class 2
Risk

K103563 is an FDA 510(k) clearance for the PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150. 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 Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on July 1, 2011 after a review of 207 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 Precision Medical, Inc. devices

FDA 510(k) Submission Details - K103563

510(k) Number K103563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2010
Decision Date July 01, 2011
Days to Decision 207 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
67d slower than avg
Panel avg: 140d · This submission: 207d
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 K103563.
Oxygen Concentrator
K172234 · Sysmed (China) Co., Ltd. · Jun 2018
Drive DeVilbiss iGo 2 Portable Oxygen Concentrator
K172648 · Devilbiss Healthcare, LLC · Mar 2018
SIMPLYGO PORTABLE OXYGEN CONCENTRATOR
K111885 · Respironics, Inc. · Nov 2011
OMNI 5 TOTAL O2 DELIVERY SYSTEM
K091028 · Respironics, Inc. · Jul 2009
PRECISION OXYGEN CONCENTRATOR
K072348 · Precision Medical, Inc. · Oct 2008
HOMELOX
K081206 · Respironics, Inc. · Jul 2008