Cleared Traditional

STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (K994321) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K994321 · Automatic Liquid Packaging, Inc. · General Hospital
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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

Submission Details

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
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.

Device Classification

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 16
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K994321.
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014
K051370 · Baxter Healthcare Corp · Aug 2005
STERILE SALINE FOR CATHETER CARE
K974397 · Baxter Healthcare Corp · Feb 1998
ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER
K950201 · Sherwood Medical Co. · Dec 1995
THORACENTESIS CATHETER
K951524 · Baxter Healthcare Corp · Jul 1995
STERILE WATER
K943773 · Medline Industries, Inc. · Feb 1995
DISPOSABLE SUCTION PROBE
K942061 · United States Surgical, A Division of Tyco Healthc · May 1994