Cleared Traditional

K981284 - BETTER-BLADDER (BB)

K981284 is the FDA 510(k) clearance for BETTER-BLADDER (BB) by Circulatory Technology, Inc.. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K981284 · Circulatory Technology, Inc. · Cardiovascular device
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Aug 1998
Decision
126d
Days
Class 2
Risk

K981284 is an FDA 510(k) clearance for the BETTER-BLADDER (BB). Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Circulatory Technology, Inc. (Oyster Bay, US). The FDA issued a Cleared decision on August 12, 1998 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Circulatory Technology, Inc. devices

Submission Details

510(k) Number K981284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1998
Decision Date August 12, 1998
Days to Decision 126 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 125d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 76
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K981284.
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K981628 · C.R. Bard, Inc. · Aug 1998
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K980935 · Terumo Medical Corp. · May 1998
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K974155 · Baxter Healthcare Corp · Jan 1998