Cleared Traditional

K901362 - ACCESSORY FITMENT TO NEBULIZER SYSTEM

K901362 is an FDA 510(k) clearance for ACCESSORY FITMENT TO NEBULIZER SYSTEM, 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 75-day FDA review.

K901362 · Automatic Liquid Packaging, Inc. · Anesthesiology device
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Jun 1990
Decision
75d
Days
Class 2
Risk

K901362 is an FDA 510(k) clearance for the ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE. 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 6, 1990 after a review of 75 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Automatic Liquid Packaging, Inc. devices

FDA 510(k) Submission Details - K901362

510(k) Number K901362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1990
Decision Date June 06, 1990
Days to Decision 75 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 140d · This submission: 75d
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 K901362.
WATER COLUMN RELIEF VALVE
K904398 · Icn Pharmaceuticals, Inc. · Jul 1991
TRACH CARE MDI ADAPTER
K900273 · Ballard Medical Products · Aug 1990
MDI ADAPTOR
K900783 · Hudson Oxygen Therapy Sales Co. · Jul 1990
STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL
K901301 · Automatic Liquid Packaging, Inc. · May 1990
IN-THE NEBULIZER
K900470 · Hudson Oxygen Therapy Sales Co. · May 1990
H.E.A.R.T. NEBULIZER
K900228 · B&B Medical Technologies, Inc. · Mar 1990