Cleared Traditional

K904434 - SEXTON CYSTOTOMY URINE PUMP (SCUP2)

K904434 is an FDA 510(k) clearance for SEXTON CYSTOTOMY URINE PUMP (SCUP2), manufactured by Phoenix Bioengineering, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOB cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K904434 · Phoenix Bioengineering, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1991
Decision
126d
Days
Class 2
Risk

K904434 is an FDA 510(k) clearance for the SEXTON CYSTOTOMY URINE PUMP (SCUP2). Classified as Catheter, Suprapubic (and Accessories) (product code KOB), Class II - Special Controls.

Submitted by Phoenix Bioengineering, Inc. (Bridgeport, US). The FDA issued a Cleared decision on February 1, 1991 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5090 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Phoenix Bioengineering, Inc. devices

FDA 510(k) Submission Details - K904434

510(k) Number K904434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1990
Decision Date February 01, 1991
Days to Decision 126 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 131d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOB Device Classification - Class 2, Special Controls

Product Code KOB Catheter, Suprapubic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5090
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 - KOB Catheter, Suprapubic (and Accessories)

All 23
Devices cleared under the same product code (KOB) and FDA review panel - the closest regulatory comparables to K904434.
LINDNER/GOLOMB SP INTRODUCING SOUND
K953024 · Cook Urological, Inc. · Aug 1995
RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE
K952187 · Rusch, Inc. · Jul 1995
SUPRAPUBIC FLOW CONTROLLER
K904798 · Olympus Corp. · Nov 1991
MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER
K901603 · Bivona Medical Technologies · May 1990
SPEC 5* SUPRAPUBIC CATHETER
K881097 · Porges Corp. · Jun 1988
VAN-TEC PEDIATRIC SUPRAPUBIC CATHETER SET
K870555 · Van-Tec, Inc. · Mar 1987