510(k) · Cleared

Cleared

Vascular Tools 5, Consisting of Brachial Analyzer 5, Carotid Analyzer 5, Vascular Imager 5 and Integrated Vascular Tools

K033266510(k) TraditionalCleared Dec 16, 2004434-day reviewClass II21 CFR 870.1425

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

Medical Imaging Applications, LLC · DQK Computer, Diagnostic, Programmable

Cleared on Dec 16, 2004 as substantially equivalent to K040227 (Philips Ultrasound, 2004) after a 434-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.

Decided: Dec 16, 2004
Review: 434 days
Class: Class II
Product code: DQK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K040227 (2004). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK040227 Qlab Quantification SoftwarePhilips Ultrasound · 2004
This deviceK033266 Vascular Tools 5, Consisting of Brachial Analyzer 5, Carotid…Medical Imaging Applications, LLC · 2004
Descendant · cites it directly · 0 of its ownK202094 Cardiovascular Suite 4.2.1Quipu S.R.L · 2022

Most influential descendants

Showing 1 of 1 · See all

K202094Cardiovascular Suite 4.2.1Quipu S.R.L · 2022 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K040227	Qlab Quantification Software	Philips Ultrasound	2004	—
0 (this device)	K033266	Vascular Tools 5, Consisting of Brachial Analyzer 5, Carotid Analyzer 5…	Medical Imaging Applications, LLC	2004	—
+1	K202094	Cardiovascular Suite 4.2.1	Quipu S.R.L	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0

FIG. 1 — Lineage of K033266, 2004–2022Source: 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 DQK? 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 DQK device

#1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	K040227	Qlab Quantification Software Cleared while this submission was under review Summary page 2 …oval. 6) Substantial equivalence Information: The "Vascular Tools 5"software is believed substantially equivalent to the predicate devices of Philips Medical Systems' K040227"QLAB QUANTIFICATION SOFTWARE" by using the same technological characteristics and identical intended use. Technological differenc…	Philips Ultrasound	2004	—

Also cleared against K040227: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K202094	Cardiovascular Suite 4.2.1	Quipu S.R.L	2022	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?

Its one ancestor has no recall.
Of its descendants, K202094 (Quipu S.R.L, 2022) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K040227.

How does its category compare?

All DQK devices

DQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQK

23so far in 2026, the most since 2007

2007high 23 (2026) · low 4 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQK

95in 2025

2007high 190 (2016) · low 64 (2010)2026

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

Recalls per year · DQK

1in 2025

2007high 24 (2024) · low 0 (2016)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQK

433in 2025

2007high 557 (2024) · low 18 (2007)2025

MAUDE reports naming product code DQK, 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	13	83	4	18
2008	4	70	1	34
2009	12	93	2	40
2010	9	64	3	49
2011	12	69	2	55
2012	7	74	3	129
2013	13	68	1	180
2014	9	90	4	115
2015	7	125	2	131
2016	15	190	0	340
2017	7	146	2	252
2018	14	150	6	261
2019	15	113	1	218
2020	16	123	1	215
2021	16	132	1	351
2022	19	136	2	319
2023	21	133	2	340
2024	13	100	24	557
2025	22	95	1	433
2026	23	151	2	—

What is it indicated for?

"Vascular Tools 5" software program has been developed to aid in quantitative analysis of longitudinal vascular ultrasound images, particularly to determine vascular diameter and intima-media thickness, as well as their changes as depicted in brachial and carotid arterial ultrasound images.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033266 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033266: Vascular Tools 5, Consisting of Brachial Analyzer 5, Carotid Analyzer 5, Vascular Imager 5 and Integrated Vascular Tools.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033266

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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