Cleared Traditional

K003402 - WELCON STERILE WATER FOR DEVICE IRRIGATION

Also marketed or referenced as:
WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION

K003402 is an FDA 510(k) clearance for WELCON STERILE WATER FOR DEVICE IRRIGATION, manufactured by Welcon, Inc.. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K003402 · Welcon, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
181d
Days
Class 2
Risk

K003402 is an FDA 510(k) clearance for the WELCON STERILE WATER FOR DEVICE IRRIGATION. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Welcon, Inc. (Ayer, US). The FDA issued a Cleared decision on May 1, 2001 after a review of 181 days - an extended review cycle.

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. Standard predicate reliance. 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 Welcon, Inc. devices

FDA 510(k) Submission Details - K003402

510(k) Number K003402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2000
Decision Date May 01, 2001
Days to Decision 181 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
52d slower than avg
Panel avg: 129d · This submission: 181d
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 50
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K003402.
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014
K051370 · Baxter Healthcare Corp · Aug 2005
STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
K994321 · Automatic Liquid Packaging, Inc. · Oct 2000
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
STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION
K973734 · Welcon, Inc. · Feb 1998