Cleared Traditional

K952910 - THE SWIRLER NEBULIZER

K952910 is an FDA 510(k) clearance for THE SWIRLER NEBULIZER, manufactured by Amici, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 632-day FDA review.

K952910 · Amici, Inc. · Anesthesiology device
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Mar 1997
Decision
632d
Days
Class 2
Risk

K952910 is an FDA 510(k) clearance for the THE SWIRLER NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Amici, Inc. (Spring City, US). The FDA issued a Cleared decision on March 19, 1997 after a review of 632 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Amici, Inc. devices

FDA 510(k) Submission Details - K952910

510(k) Number K952910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1995
Decision Date March 19, 1997
Days to Decision 632 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
492d slower than avg
Panel avg: 140d · This submission: 632d
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 349
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K952910.
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JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009
K970035 · Graham-Field, Inc. · Apr 1997
THERA-MIST NEBULIZER MODEL-P3000
K962534 · Pegasus Research Corp. · Feb 1997
RESPIFLO
K962872 · Tyco Healthcare Deutschaland GmbH · Feb 1997
RESPIFLO/S
K962874 · Curtin & Associates International , Inc. · Feb 1997