Cleared Traditional

K884018 - LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT

K884018 is an FDA 510(k) clearance for LAMELLI OXYGEN ENRICHED ENVIRONMENT SYS..., manufactured by Lamelli Pulmonary Research Center. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K884018 · Lamelli Pulmonary Research Center · Anesthesiology device
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Feb 1989
Decision
158d
Days
Class 2
Risk

K884018 is an FDA 510(k) clearance for the LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT. 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 Lamelli Pulmonary Research Center (Ontario, US). The FDA issued a Cleared decision on February 27, 1989 after a review of 158 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.

FDA 510(k) Submission Details - K884018

510(k) Number K884018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1988
Decision Date February 27, 1989
Days to Decision 158 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 140d · This submission: 158d
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 233
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K884018.
MODEL 590 OXYGEN CONCENTRATOR
K895141 · Puritan Bennett Corp. · Oct 1989
K.E.E. OXYGEN CONCENTRATOR
K894384 · Kee Medical Services, Inc. · Oct 1989
MOBILAIRE V OXYGEN CONCENTRATOR
K891488 · Invacare Corp. · May 1989
H-3000 OXYGEN CONCENTRATOR
K890150 · Healthdyne, Inc. · Jan 1989
RELIANT OXYGEN CONCENTRATOR
K884581 · Airsep Corp. · Jan 1989
PORTABLE OXYGEN GENERATOR
K884084 · Mountain Medical Equipment, Inc. · Nov 1988
K884018 · LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT
Download PDF Lamelli Pulmonary Res…