Cleared Traditional

K964337 - BETTER-BLADDER (BB)

K964337 is an FDA 510(k) clearance for BETTER-BLADDER (BB), manufactured by Circulatory Technology, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIB cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K964337 · Circulatory Technology, Inc. · Gastroenterology & Urology device
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May 1997
Decision
204d
Days
Class 2
Risk

K964337 is an FDA 510(k) clearance for the BETTER-BLADDER (BB). Classified as Protector, Transducer, Dialysis (product code FIB), Class II - Special Controls.

Submitted by Circulatory Technology, Inc. (Oyster Bay, US). The FDA issued a Cleared decision on May 23, 1997 after a review of 204 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 Circulatory Technology, Inc. devices

FDA 510(k) Submission Details - K964337

510(k) Number K964337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1996
Decision Date May 23, 1997
Days to Decision 204 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 131d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIB Device Classification - Class 2, Special Controls

Product Code FIB Protector, Transducer, Dialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - FIB Protector, Transducer, Dialysis

All 16
Devices cleared under the same product code (FIB) and FDA review panel - the closest regulatory comparables to K964337.
FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
K003445 · Fresenius Medical Care North America · Dec 2000
BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
K000702 · Fresenius Medical Care North America · Jun 2000
MEDISYSTEMS TRANSDUCER PROTECTOR
K983076 · Medisystems Corp. · Nov 1998
MEDISYSTEMS TRANDUCER PROTECTOR
K970536 · Medisystems Corp. · May 1997
MILLEX, DUALEX (PLUS, ULTRA)
K934069 · Millipore Corp. · Apr 1994
TRANSDUCER PROTECTOR
K910821 · Gelman Sciences, Inc. · Aug 1991