510(k) · Cleared

Cleared

Millar Pressure Control Unit Model Pcu-2000

K013205510(k) TraditionalCleared Jul 2, 2002280-day reviewClass II21 CFR 870.2060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Millar Instruments, Inc. · DRQ Amplifier And Signal Conditioner, Transducer Signal

Cleared on Jul 2, 2002 after a 280-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Jul 2, 2002
Review: 280 days
Class: Class II
Product code: DRQ
Recalls: None
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K013205Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DRQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All DRQ devices

DRQ Amplifier And Signal Conditioner, Transducer Signal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRQ

1in 2017

2007high 2 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRQ

Too few DRQ 510(k)s in any year since 2007 to give a median.

Recalls per year · DRQ

No recall names DRQ since 2007.

Adverse event reports per year · DRQ

3in 2025

2007high 8 (2023) · low 0 (2007)2025

MAUDE reports naming product code DRQ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	2	—	1
2016	0	—	2
2017	1	—	3
2018	0	—	1
2019	0	—	0
2020	0	—	5
2021	0	—	4
2022	0	—	6
2023	0	—	8
2024	0	—	5
2025	0	—	3
2026	0	—	—

What is it indicated for?

Read the full statement (129 words)

The PCU-2000 Pressure Control Unit is a two-channel electrically isolated amplifier that is intended for use with Millar Mikro-Tip Pressure Catheters that have the standard medical sensitivity of 5 microvolts per mmHg of applied pressure and a 1 volt of bridge excitation. The PCU-2000 provides an electrical interface between a physiological pressure transducer and a data acquisition module or medical monitor. It is intended for use in monitoring diagnostic pressures, such as noninvasive or invasive blood pressures, intracranial pressures, gastrointestinal pressures, esophageal pressures, urinary tract pressures, intrauterine pressures, intraocular pressures and other physiological pressures with similar ranges. It is intended for use in critical care areas in a hospital and in diagnostic centers in hospitals or medical clinics. It is intended for use by trained clinicians or research personnel

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K013205 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013205: Millar Pressure Control Unit Model Pcu-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013205

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Page last updated Nov 3, 2026