Cleared Traditional

K081267 - HYGEIA-5 OXYGEN CONCENTRATOR

K081267 is an FDA 510(k) clearance for HYGEIA-5 OXYGEN CONCENTRATOR, manufactured by Kedl Internation Limited. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K081267 · Kedl Internation Limited · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
141d
Days
Class 2
Risk

K081267 is an FDA 510(k) clearance for the HYGEIA-5 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 Kedl Internation Limited (Fort Myers, US). The FDA issued a Cleared decision on September 23, 2008 after a review of 141 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 Kedl Internation Limited devices

FDA 510(k) Submission Details - K081267

510(k) Number K081267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2008
Decision Date September 23, 2008
Days to Decision 141 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 140d · This submission: 141d
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 121
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K081267.
OMNI 5 TOTAL O2 DELIVERY SYSTEM
K091028 · Respironics, Inc. · Jul 2009
INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100
K083751 · Invacare Corporation · May 2009
PRECISION OXYGEN CONCENTRATOR
K072348 · Precision Medical, Inc. · Oct 2008
HOMELOX
K081206 · Respironics, Inc. · Jul 2008
THE INVACARE FLYER, MODEL IPC 100
K071928 · Invacare Corp. · Dec 2007
L4 OXYGEN CONCENTRATOR
K061261 · Respironics, Inc. · Jun 2006