Cleared Traditional

K910653 - TOUCHLESS II INTERMITTENT CATHETER

K910653 is an FDA 510(k) clearance for TOUCHLESS II INTERMITTENT CATHETER, manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCM cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K910653 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1991
Decision
81d
Days
Class 2
Risk

K910653 is an FDA 510(k) clearance for the TOUCHLESS II INTERMITTENT CATHETER. Classified as Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (product code FCM), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on May 6, 1991 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K910653

510(k) Number K910653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1991
Decision Date May 06, 1991
Days to Decision 81 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 131d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCM Device Classification - Class 2, Special Controls

Product Code FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)

All 34
Devices cleared under the same product code (FCM) and FDA review panel - the closest regulatory comparables to K910653.
CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER
K950109 · Cypress Medical Products, Ltd. · Feb 1995
FOLEY CATHETERIZATION TRAY
K942177 · Customed, Inc. · Sep 1994
MON-A-THERM FOLEY KIT
K923538 · Mallinckrodt Medical · May 1993
FOLEY CATHETER INSERTION TRAY (30CC)
K901180 · Orion Life Systems, Inc. · Jul 1990
CATHETER CARE TRAY
K901181 · Orion Life Systems, Inc. · Jul 1990
URETHRAL CATHETER TRAY (PVC)
K901183 · Orion Life Systems, Inc. · Jul 1990