Cleared Special

K000964 - STERILE WATER OR O.9% SODIUM CHLORIDE

K000964 is an FDA 510(k) clearance for STERILE WATER OR O.9% SODIUM CHLORIDE, manufactured by Automatic Liquid Packaging, Inc.. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Special 510(k) pathway after a 29-day FDA review.

K000964 · Automatic Liquid Packaging, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
29d
Days
Class 2
Risk

K000964 is an FDA 510(k) clearance for the STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Automatic Liquid Packaging, Inc. (Woodstock, US). The FDA issued a Cleared decision on April 25, 2000 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Automatic Liquid Packaging, Inc. devices

FDA 510(k) Submission Details - K000964

510(k) Number K000964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2000
Decision Date April 25, 2000
Days to Decision 29 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 140d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

JOH Device Classification - Class 2, Special Controls

Product Code JOH Tube Tracheostomy And Tube Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
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 - JOH Tube Tracheostomy And Tube Cuff

All 70
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K000964.
RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
K023918 · Rusch Intl. · Mar 2003
TRACH VOX
K013728 · Engineered Medical Systems · Jul 2002
THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY
K011210 · Rusch Intl. · Aug 2001
RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET
K972546 · Rusch Intl. · Apr 1998
IRRIGATION BOTTLE
K973829 · Automatic Liquid Packaging, Inc. · Feb 1998
RUSCH TRACHEOFIX-SET
K972423 · Rusch Intl. · Feb 1998