Cleared Traditional

WELCON STERILE WATER FOR DEVICE IRRIGATION (K003402) - FDA 510(k) Clearance

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

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

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

Submission Details

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.

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 83
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 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