510(k) · Cleared

Cleared

Pressure Wire Sensor .014, Pressure Wire Interface 10, Pressure Wire Monitor Cable

K972793510(k) TraditionalCleared Apr 24, 1998270-day reviewClass II21 CFR 870.1330

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

Radi Medical Systems AB · DQX Wire, Guide, Catheter

Cleared on Apr 24, 1998 after a 270-day review. The FDA summary names its predicate without a number. 15 later devices descend from it.

Decided: Apr 24, 1998
Review: 270 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 0

15 later devices descend from it, 2 citing it directly.

This deviceK972793 Pressure Wire Sensor .014, Pressure Wire Interface 10, Pressure Wire…Radi Medical Systems AB · 1998
Descendant · cites it directly · 13 of its ownK080813 Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB · 2008
Descendant · 2 generations on · 8 of its ownK113584 Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical · 2012
Descendant · 3 generations on · 7 of its ownK131452 Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB · 2013
Descendant · 4 generations on · 2 of its ownK140466 Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile…St. Jude Medical Systems AB · 2014
Descendant · 2 generations on · 2 of its ownK111201 C7 XR Imaging SystemLightlab Imaging, Inc. · 2011

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

1999high 3 (2019) · low 0 (2000)2026

Most influential descendants

Showing 5 of 15 · See all

K080813Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB · 2008 · cites it directly13descendants
K113584Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical · 2012 · 2 generations on8descendants
K131452Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB · 2013 · 3 generations on7descendants
K140466Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300St. Jude Medical Systems AB · 2014 · 4 generations on2descendants
K111201C7 XR Imaging SystemLightlab Imaging, Inc. · 2011 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K972793	Pressure Wire Sensor .014, Pressure Wire Interface 10, Pressure Wire Monitor…	Radi Medical Systems AB	1998	—
+1	K080813	Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver	Radi Medical Systems AB	2008	—
+2	K113584	Pressurewire Certus, Certus 300, Aeris, Aeris 300, and Receiver	St Jude Medical	2012	—
+3	K131452	Pressurewire; Certus, Certus 300, Aeris, Aeris 300	St. Jude Medical Systems AB	2013	—
+4	K140466	Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus…	St. Jude Medical Systems AB	2014	—
+2	K111201	C7 XR Imaging System	Lightlab Imaging, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2008	1	0
2011	2	0
2012	1	0
2013	2	0
2014	1	0
2015	2	0
2016	1	0
2018	1	0
2019	3	0

FIG. 1 — Lineage of K972793, 1998–2019Source: 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 DQX? 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 DQX device

#1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

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
*	—	ACS Guidewires Named without a submission number			—
*	—	Millar Pressure Measurement System Named without a submission number			—

What descends from it? (15)

See all 15

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K080813	Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver	Radi Medical Systems AB	2008	13
K983506	Pressurewire Sensor, Model #12001	Radi Medical Systems AB	1999	0

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?

Of its descendants, K080813 (Radi Medical Systems AB, 2008) has gone furthest, with 13 descendants of its own.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQX

10in 2025

2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007high 212 (2022) · low 43 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQX

3in 2024

2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007high 2,210 (2024) · low 687 (2009)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	14	85	12	760
2008	19	87	7	715
2009	18	87	49	687
2010	21	63	34	987
2011	18	43	3	1,311
2012	20	62	5	1,337
2013	18	119	7 (4)	1,474
2014	18	103	0	1,323
2015	15	112	1	1,323
2016	14	179	2 (2)	1,466
2017	19	85	17	1,524
2018	19	114	9	1,737
2019	13	173	2	1,679
2020	14	106	1 (1)	1,536
2021	6	161	0	1,713
2022	15	212	0	1,647
2023	10	136	0	2,068
2024	11	134	3	2,210
2025	10	177	0	2,178
2026	12	145	4 (1)	—

What is it indicated for?

The PressureWire™ System is indicated for the measurement of blood pressure in the coronary vasculature and to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K972793 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972793: Pressure Wire Sensor .014, Pressure Wire Interface 10, Pressure Wire Monitor Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972793

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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