Cleared Special

K140321 - INITARY BETTER BLADDER-PEDIATRIC

K140321 is the FDA 510(k) clearance for INITARY BETTER BLADDER-PEDIATRIC by Circulatory Technology, Inc.. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Special 510(k) pathway after a 58-day FDA review.

K140321 · Circulatory Technology, Inc. · Cardiovascular device
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Apr 2014
Decision
58d
Days
Class 2
Risk

K140321 is an FDA 510(k) clearance for the INITARY BETTER BLADDER-PEDIATRIC. 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 April 17, 2014 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Circulatory Technology, Inc. devices

Submission Details

510(k) Number K140321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2014
Decision Date April 17, 2014
Days to Decision 58 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

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
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