Cleared Traditional

K915211 - MICROCHAMBER

K915211 is an FDA 510(k) clearance for MICROCHAMBER, manufactured by Respiratory Delivery Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K915211 · Respiratory Delivery Systems, Inc. · Anesthesiology device
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May 1992
Decision
184d
Days
Class 2
Risk

K915211 is an FDA 510(k) clearance for the MICROCHAMBER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Respiratory Delivery Systems, Inc. (Lowell, US). The FDA issued a Cleared decision on May 20, 1992 after a review of 184 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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 - K915211

510(k) Number K915211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1991
Decision Date May 20, 1992
Days to Decision 184 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 140d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 443
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K915211.
NE-U04/NE U04F
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MININEB
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HEART NUBULIZER
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OMRON COMPRESSOR NEBULIZER- MODEL NE-C09
K914836 · Omron Healthcare, Inc. · May 1992
DP 100
K911192 · Ferguson Medical · Dec 1991
DEVILBISS MODEL 7427D
K913316 · Devilbiss Health Care, Inc. · Dec 1991