Cleared Traditional

K051887 - PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)

K051887 is an FDA 510(k) clearance for PATIENT VENTILATION OXYGEN CONCENTRATIN..., manufactured by Carleton Life Support Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K051887 · Carleton Life Support Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
77d
Days
Class 2
Risk

K051887 is an FDA 510(k) clearance for the PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF). 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 Carleton Life Support Systems, Inc. (Davenport, US). The FDA issued a Cleared decision on September 27, 2005 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K051887

510(k) Number K051887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2005
Decision Date September 27, 2005
Days to Decision 77 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
63d faster than avg
Panel avg: 140d · This submission: 77d
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 224
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K051887.
OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615
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LONGFEI LFY-I-5 OXYGEN CONCENTRATOR
K033405 · Zhejiang Longfei Industrial Co., Ltd. · Oct 2005
OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03
K033863 · Ox-Gen, Inc. · Aug 2005
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR
K050430 · Merits Health Products Co., Ltd. · Aug 2005
HOME-AWAY SYSTEM, MODEL 1041
K042944 · In-X Corporation · Apr 2005