Cleared Traditional

K091191 - GAS TRANSFILL

K091191 is an FDA 510(k) clearance for GAS TRANSFILL, manufactured by Respironics Inc., Sleep & Home Respiratory Group. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K091191 · Respironics Inc., Sleep & Home Respiratory Group · Anesthesiology device
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Oct 2009
Decision
183d
Days
Class 2
Risk

K091191 is an FDA 510(k) clearance for the GAS TRANSFILL. 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 Respironics Inc., Sleep & Home Respiratory Group (Murrysville, US). The FDA issued a Cleared decision on October 23, 2009 after a review of 183 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 Respironics Inc., Sleep & Home Respiratory Group devices

FDA 510(k) Submission Details - K091191

510(k) Number K091191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2009
Decision Date October 23, 2009
Days to Decision 183 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
43d slower than avg
Panel avg: 140d · This submission: 183d
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 K091191.
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
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