510(k) · Cleared

Cleared

Radianalyzer, Model 12710, Radiview (PC-Software Accessory), Model 12720

K013943510(k) SpecialCleared Dec 18, 200119-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

Radi Medical Systems AB · DSK Computer, Blood-Pressure

Cleared on Dec 18, 2001 as substantially equivalent to K002067 (Radi Medical Systems AB, 2001) after a 19-day review. Its family tree reaches back 1 generation to 2001. 47 later devices descend from it.

Decided: Dec 18, 2001
Review: 19 days
Class: Class II
Product code: DSK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K002067 (2001). 47 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK002067 Radianalyzer, Model 12710Radi Medical Systems AB · 2001
This deviceK013943 Radianalyzer, Model 12710, Radiview (PC-Software Accessory), Model…Radi Medical Systems AB · 2001
Descendant · cites it directly · 46 of its ownK022188 Radianalyzer, Model 12710Radi Medical Systems AB · 2002
Descendant · 2 generations on · 26 of its ownK042628 Modification to: Radianalyzer, Model 12711Radi Medical Systems AB · 2005
Descendant · 2 generations on · 26 of its ownK031662 Pressure Wire Sensor, Models 12004/12304Radi Medical Systems AB · 2003
Descendant · cites it directly · 25 of its ownK092105 Radianalyzer XpressRadi Medical Systems AB · 2009
Descendant · 3 generations on · 25 of its ownK062769 Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB · 2006

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

2002high 7 (2019) · low 0 (2004)2026

Most influential descendants

Showing 5 of 47 · See all

K022188Radianalyzer, Model 12710Radi Medical Systems AB · 2002 · cites it directly46descendants
K042628Modification to: Radianalyzer, Model 12711Radi Medical Systems AB · 2005 · 2 generations on26descendants
K031662Pressure Wire Sensor, Models 12004/12304Radi Medical Systems AB · 2003 · 2 generations on26descendants
K092105Radianalyzer XpressRadi Medical Systems AB · 2009 · cites it directly25descendants
K062769Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB · 2006 · 3 generations on25descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002067	Radianalyzer, Model 12710	Radi Medical Systems AB	2001	—
0 (this device)	K013943	Radianalyzer, Model 12710, Radiview (PC-Software Accessory), Model 12720	Radi Medical Systems AB	2001	—
+1	K022188	Radianalyzer, Model 12710	Radi Medical Systems AB	2002	—
+2	K042628	Modification to: Radianalyzer, Model 12711	Radi Medical Systems AB	2005	—
+2	K031662	Pressure Wire Sensor, Models 12004/12304	Radi Medical Systems AB	2003	—
+1	K092105	Radianalyzer Xpress	Radi Medical Systems AB	2009	—
+3	K062769	Pressurewire Certus, Models 12006 and 12306	Radi Medical Systems AB	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2005	1	0
2006	1	0
2008	1	0
2009	1	0
2011	2	0
2012	1	0
2013	3	0
2014	2	0
2015	5	0
2016	3	0
2017	3	0
2018	2	0
2019	7	0
2020	3	0
2021	2	0
2022	1	0
2023	4	0
2024	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K013943, 2001–2026Source: 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

Get a 510(k) Report

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
*	K002067	Radianalyzer, Model 12710 Summary page 1 …Name: RadiAnalyzer™ System Common Name: Blood Pressure Computer Classification Name: §870.1110 Blood Pressure Computer Predicate Device: RadiAnalyzer™ System 510(k) # K002067 Description of the Device: The RadiAnalyzer™ is a blood pressure computer, to be used as a diagnostic tool when the diagnosis is…	Radi Medical Systems AB	2001	—

Also cleared against K002067: 1 other device →

What descends from it? (47)

See all 47

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

Number	Device	Applicant	Decided	Descendants
K022188	Radianalyzer, Model 12710	Radi Medical Systems AB	2002	46
K092105	Radianalyzer Xpress	Radi Medical Systems AB	2009	25

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.
Of its descendants, K022188 (Radi Medical Systems AB, 2002) has gone furthest, with 46 descendants of its own.
1 other device also cites its predicate K002067.

How does its category compare?

All DSK devices

DSK Computer, Blood-Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 RadiAnalyzer is intended for use under the direction of a licensed physician to calculate, display and record vascular data. Data is acquired from a PressureWire Sensor and an External Pressure Transducer (EPT).

The information is displayed on the integrated screen and/or transferred to a cardiac monitor. Data includes: systolic, diastolic and mean blood pressure, heart rate, and Fractional Flow Reserve (FFR).

The RadiAnalyzer is intended for use in catheterization and related cardiovascular specially laboratories.

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/K013943 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013943: Radianalyzer, Model 12710, Radiview (PC-Software Accessory), Model 12720.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013943

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Record history

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