Cleared Traditional

K003145 - ORIGEN BLADDER HOLDER

K003145 is an FDA 510(k) clearance for ORIGEN BLADDER HOLDER, manufactured by Origen Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DWC cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K003145 · Origen Biomedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Apr 2001
Decision
192d
Days
Class 2
Risk

K003145 is an FDA 510(k) clearance for the ORIGEN BLADDER HOLDER. Classified as Controller, Temperature, Cardiopulmonary Bypass (product code DWC), Class II - Special Controls.

Submitted by Origen Biomedical, Inc. (Austin, US). The FDA issued a Cleared decision on April 20, 2001 after a review of 192 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4250 - 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 Origen Biomedical, Inc. devices

FDA 510(k) Submission Details - K003145

510(k) Number K003145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2000
Decision Date April 20, 2001
Days to Decision 192 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
67d slower than avg
Panel avg: 125d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWC Device Classification - Class 2, Special Controls

Product Code DWC Controller, Temperature, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4250
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - DWC Controller, Temperature, Cardiopulmonary Bypass

All 15
Devices cleared under the same product code (DWC) and FDA review panel - the closest regulatory comparables to K003145.
TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
K071521 · Terumo Cardiovascular Systems Corp. · Nov 2007
STOCKERT HEATER-COOLER SYSTEM 3T
K052601 · Sorin Group Deutschland GmbH · Jun 2006
ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER
K014016 · Minntech Corp. · Feb 2002
SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
K883603 · 3M Health Care, Sarns · Nov 1988
PTI HEART-CHILL POUCH/PAD SLING (STERILE)
K873924 · Buckman Co., Inc. · Feb 1988
PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET
K874927 · Pioneering Technologies, Inc. · Jan 1988