Cleared Traditional

K955104 - HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER

K955104 is an FDA 510(k) clearance for HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER, manufactured by Automatic Liquid Packaging, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K955104 · Automatic Liquid Packaging, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
216d
Days
Class 2
Risk

K955104 is an FDA 510(k) clearance for the HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Automatic Liquid Packaging, Inc. (Woodstock, US). The FDA issued a Cleared decision on June 11, 1996 after a review of 216 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.

View all Automatic Liquid Packaging, Inc. devices

FDA 510(k) Submission Details - K955104

510(k) Number K955104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1995
Decision Date June 11, 1996
Days to Decision 216 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
76d slower than avg
Panel avg: 140d · This submission: 216d
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 218
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K955104.
SALTER LABS 8990 SERIES NEBULIZER
K962085 · Salter Labs · Aug 1996
BAXTER NEBULIZER CAP MODEL 2D0868
K962161 · Baxter Healthcare Corp · Aug 1996
SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
K961476 · Salter Labs · Jul 1996
JET NEBULIZER
K952249 · Devilbiss Health Care, Inc. · Jan 1996
DEVILBISS MODEL 5500
K946095 · Devilbiss Health Care, Inc. · Aug 1995
CAREPAK
K942350 · Precision Medical, Inc. · Dec 1994