510(k) · Cleared

Cleared

CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box

K152582510(k) SpecialCleared Dec 3, 201584-day reviewClass II21 CFR 870.1110

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

Volcano Corporation · DSK Computer, Blood-Pressure

Cleared on Dec 3, 2015 as substantially equivalent to K133641 (Volcano Corporation, 2013) after an 84-day review. Its family tree reaches back 1 generation to 2013.

Decided: Dec 3, 2015
Review: 84 days
Class: Class II
Product code: DSK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K133641 (2013). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK133641 Core Control Pad, Core Series SW V3.4 Installation Kit, Core, Core…Volcano Corporation · 2013
This deviceK152582 CORE FM System, Patient Interface Module (OPIM), Hemodynamic…Volcano Corporation · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K133641	Core Control Pad, Core Series SW V3.4 Installation Kit, Core, Core Mobile	Volcano Corporation	2013	—
0 (this device)	K152582	CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box	Volcano Corporation	2015	—

FIG. 1 — Lineage of K152582, 2013–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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

Top candidate predicates for a new DSK device

#1 K231586 Endophys Blood Pressure Monitor model BPM-30score 8.7 · 9 generations · no Class I recall

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K133641	Core Control Pad, Core Series SW V3.4 Installation Kit, Core, Core Mobile Summary page 4 …rical Cable Class II Device PREDICATE DEVICE: CORE Control Pad, CORE Series SW v3.4 Installation Kit, CORE, CORE Mobile (K133641) DEVICE DESCRIPTION: The CORE FM System provides the capability to make Fractional Flow Reserve (FFR) an…	Volcano Corporation	2013	—

Also cleared against K133641: 2 other devices →

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.

What does this lineage say?

Its one ancestor has no recall.
2 other devices also cite its predicate K133641.

How does its category compare?

All DSK devices

DSK Computer, Blood-Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · DSK

1in 2023

2007high 2 (2015) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSK

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

Recalls per year · DSK

No recall names DSK since 2007.

Adverse event reports per year · DSK

26in 2025

2007high 148 (2019) · low 0 (2007)2025

MAUDE reports naming product code DSK, 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	1	—	0
2008	1	—	0
2009	0	—	0
2010	0	—	10
2011	0	—	5
2012	0	—	69
2013	0	—	5
2014	0	—	8
2015	2	—	7
2016	1	—	13
2017	0	—	6
2018	0	—	93
2019	0	—	148
2020	0	—	29
2021	0	—	31
2022	0	—	29
2023	1	—	14
2024	0	—	12
2025	0	—	26
2026	0	—	—

What is it indicated for?

The CORE® FM System is intended to measure blood pressure in all blood vessels, including the coronary and peripheral arteries during diagnostic and/or interventional procedures.

The CORE FM System should be used only by physicians who are thoroughly trained in cardiac or peripheral vessel catheterization procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K152582 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152582: CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152582

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026