Cleared Traditional

K994321 - STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP

K994321 is an FDA 510(k) clearance for STERILE WATER AND 0.9% SODIUM CHLORIDE ..., manufactured by Automatic Liquid Packaging, Inc.. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K994321 · Automatic Liquid Packaging, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
308d
Days
Class 2
Risk

K994321 is an FDA 510(k) clearance for the STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Automatic Liquid Packaging, Inc. (Woodstock, US). The FDA issued a Cleared decision on October 25, 2000 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Automatic Liquid Packaging, Inc. devices

FDA 510(k) Submission Details - K994321

510(k) Number K994321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1999
Decision Date October 25, 2000
Days to Decision 308 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 129d · This submission: 308d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOL Device Classification - Class 2, Special Controls

Product Code JOL Catheter And Tip, Suction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 General Hospital devices follow this clearance model.

Regulatory Peers - JOL Catheter And Tip, Suction

All 59
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K994321.
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
K000265 · Primary Care Solutions, Inc. · Jul 2001
PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
K000266 · Primary Care Solutions, Inc. · Jul 2001
WELCON STERILE WATER FOR DEVICE IRRIGATION
K003402 · Welcon, Inc. · May 2001
HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE
K974758 · Hydrox Laboratories · Mar 1998
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE
K974759 · Hydrox Laboratories · Mar 1998
STERILE SALINE FOR CATHETER CARE
K974397 · Baxter Healthcare Corp · Feb 1998