Cleared Traditional

K981284 - BETTER-BLADDER (BB)

K981284 is an FDA 510(k) clearance for BETTER-BLADDER (BB), manufactured by Circulatory Technology, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K981284

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
Combination Product No
PCCP Authorized No
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.

DTN Device Classification - Class 2, Special Controls

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 146
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K981284.
COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K984456 · Cobe Cardiovascular, Inc. · Jan 1999
CAPIOX SX HARDSHELL RESEVOIR
K982223 · Terumo Medical Corp. · Sep 1998
COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800
K980786 · Cobe Cardiovascular, Inc. · Aug 1998
BARD QUANTUM SVR MODEL NUMBER H-6440VR
K981628 · C.R. Bard, Inc. · Aug 1998
CAPIOX SX HARDSHELL RESERVOIR
K980935 · Terumo Medical Corp. · May 1998
BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT
K974155 · Baxter Healthcare Corp · Jan 1998