Cleared Traditional

K950201 - ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER

K950201 is an FDA 510(k) clearance for ARGYLE HYDROPHILIC COATED THORACIC CATHETER, manufactured by Sherwood Medical Co.. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K950201 · Sherwood Medical Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
331d
Days
Class 2
Risk

K950201 is an FDA 510(k) clearance for the ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on December 15, 1995 after a review of 331 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 Sherwood Medical Co. devices

FDA 510(k) Submission Details - K950201

510(k) Number K950201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1995
Decision Date December 15, 1995
Days to Decision 331 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
202d slower than avg
Panel avg: 129d · This submission: 331d
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 49
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K950201.
STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION
K973734 · Welcon, Inc. · Feb 1998
GERM TRAPPER SUCTION TUBE HOLDER
K972372 · Rzv Medical Specialties, Inc. · Dec 1997
CPR SUCTION CATHETER KIT
K960216 · Custom Pack Reliability · Apr 1996
THORACENTESIS CATHETER
K951524 · Baxter Healthcare Corp · Jul 1995
STERILE WATER
K943773 · Medline Industries, Inc. · Feb 1995
STERILE WATER FOR IRRIGATION
K943828 · Orion Life Systems, Inc. · Nov 1994