510(k) · Cleared

Cleared

Stethoflux

K060064510(k) TraditionalCleared Apr 10, 200691-day reviewClass II21 CFR 892.1540

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

Odvi · JAF Monitor, Ultrasonic, Nonfetal

Cleared on Apr 10, 2006 as substantially equivalent to K030466 (Elcat, GmbH, 2003) after a 91-day review. Its family tree reaches back 3 generations to 1994.

Decided: Apr 10, 2006
Review: 91 days
Class: Class II
Product code: JAF
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K930200 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
2 generations backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
1 generation backK030466 HandydopElcat, GmbH · 2003
This deviceK060064 StethofluxOdvi · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K930200	Multi Dopplex II / Fetal Dopplex II	Huntleigh Healthcare, Inc.	1994	—
−2	K991441	Cadence Doppler Ultrasound System	Medasonics, Inc.	1999	—
−1	K030466	Handydop	Elcat, GmbH	2003	—
0 (this device)	K060064	Stethoflux	Odvi	2006	—

FIG. 1 — Lineage of K060064, 1994–2006Source: 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 JAF? 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 JAF device

#1 K242487 Laminar P1 (LDH-HW-001)score 10.3 · 7 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
*	K030466	Handydop Summary page 1 …low, class ;I according to 21CFR 884 2660 884 2660 Fetal ultrasonic monitor and accessories 3 Predicate substantially K030466 HandyDop TM Ecat GmbH equivalent device 4 Description of the device Acoustic stethoscope with ultrasonic transduce…	Elcat, GmbH	2003	—

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?

The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
None of the 3 ancestors has a recall.

How does its category compare?

All JAF devices

JAF Monitor, Ultrasonic, Nonfetal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAF

1in 2024

2007high 2 (2009) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAF

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

Recalls per year · JAF

No recall names JAF since 2007.

Adverse event reports per year · JAF

1in 2023

2007high 44 (2017) · low 0 (2007)2025

MAUDE reports naming product code JAF, 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	2	—	0
2010	0	—	1
2011	1	—	0
2012	0	—	1
2013	0	—	2
2014	0	—	8
2015	1	—	7
2016	0	—	5
2017	0	—	44
2018	0	—	1
2019	0	—	2
2020	0	—	5
2021	0	—	1
2022	0	—	2
2023	0	—	1
2024	1	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

Diagnostic ultrasound blood flow detection of the human body

The Stethoflux,® is designed for use by general practitioners or specialists on their own responsibility. It alioc.s dual sterhoscopic and doppler peripheral vascuar :nvestication in a simpTe auscultation.

it facilitates

- the detection of blood-flow in the peripheral arteries

- Systolic Blood Pressures (SBP) measurements of the lower limb and upper-limb in order to determine the posssbie PAD ankle Br3ch'al index (ABI) in the concerned iimb. when associated with a sphygmcmancrneter

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060064 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060064: Stethoflux.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060064

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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