Cleared Traditional

K013205 - MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000

K013205 is an FDA 510(k) clearance for MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000, manufactured by Millar Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DRQ cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K013205 · Millar Instruments, Inc. · Cardiovascular device
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Jul 2002
Decision
280d
Days
Class 2
Risk

K013205 is an FDA 510(k) clearance for the MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000. Classified as Amplifier And Signal Conditioner, Transducer Signal (product code DRQ), Class II - Special Controls.

Submitted by Millar Instruments, Inc. (Houston, US). The FDA issued a Cleared decision on July 2, 2002 after a review of 280 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2060 - 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 Millar Instruments, Inc. devices

FDA 510(k) Submission Details - K013205

510(k) Number K013205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2001
Decision Date July 02, 2002
Days to Decision 280 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 125d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRQ Device Classification - Class 2, Special Controls

Product Code DRQ Amplifier And Signal Conditioner, Transducer Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2060
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 - DRQ Amplifier And Signal Conditioner, Transducer Signal

All 15
Devices cleared under the same product code (DRQ) and FDA review panel - the closest regulatory comparables to K013205.
BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO
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SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER
K020277 · Siemens Medical Solutions USA, Inc. · Feb 2002
SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER
K010640 · Siemens Medical Solutions USA, Inc. · Mar 2001
BARD BIOPOTENTIAL AMPLIFIER II
K901358 · C.R. Bard, Inc. · May 1990