510(k) · Cleared

Cleared

Cadence Doppler Ultrasound System

K991441510(k) TraditionalCleared Dec 28, 1999246-day reviewClass II21 CFR 884.2660

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

Medasonics, Inc. · KNG Monitor, Ultrasonic, Fetal

Cleared on Dec 28, 1999 as substantially equivalent to K930200 (Huntleigh Healthcare, Inc., 1994) after a 246-day review. Its family tree reaches back 1 generation to 1994. 44 later devices descend from it.

Decided: Dec 28, 1999
Review: 246 days
Class: Class II
Product code: KNG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K930200 (1994). 44 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
This deviceK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
Descendant · cites it directly · 31 of its ownK024197 Lifedop DopplerSummit Doppler Systems, Inc. · 2003 · Recalled
Descendant · cites it directly · 21 of its ownK040480 Sonotrax Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2004
Descendant · 2 generations on · 13 of its ownK080087 Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite…Edan Instruments, Inc. · 2008
Descendant · 2 generations on · 12 of its ownK082480 Contec Pocket Fetal DopplerContec Medical System Co., Ltd. · 2009
Descendant · 3 generations on · 9 of its ownK100626 Doppler Fetal Heart Rate Detector, Model FM-200Shenzhen Biocare Electronics Co., Ltd. · 2010

Showing 5 of 44 descendants. See all descendants

Descendants cleared per year

2002high 6 (2010) · low 0 (2007)2026

Most influential descendants

Showing 5 of 44 · See all

K024197Lifedop DopplerSummit Doppler Systems, Inc. · 2003 · cites it directly31descendants
K040480Sonotrax Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2004 · cites it directly21descendants
K080087Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic, Pro, II, II…Edan Instruments, Inc. · 2008 · 2 generations on13descendants
K082480Contec Pocket Fetal DopplerContec Medical System Co., Ltd. · 2009 · 2 generations on12descendants
K100626Doppler Fetal Heart Rate Detector, Model FM-200Shenzhen Biocare Electronics Co., Ltd. · 2010 · 3 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K930200	Multi Dopplex II / Fetal Dopplex II	Huntleigh Healthcare, Inc.	1994	—
0 (this device)	K991441	Cadence Doppler Ultrasound System	Medasonics, Inc.	1999	—
+1	K024197	Lifedop Doppler	Summit Doppler Systems, Inc.	2003	1
+1	K040480	Sonotrax Ultrasonic Pocket Doppler	Edan Instruments, Inc.	2004	—
+2	K080087	Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic…	Edan Instruments, Inc.	2008	—
+2	K082480	Contec Pocket Fetal Doppler	Contec Medical System Co., Ltd.	2009	—
+3	K100626	Doppler Fetal Heart Rate Detector, Model FM-200	Shenzhen Biocare Electronics Co., Ltd.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	4	0
2004	1	0
2005	1	0
2006	2	0
2008	1	0
2009	5	0
2010	6	0
2011	4	0
2014	1	0
2015	3	0
2016	1	0
2018	3	0
2019	4	0
2021	1	0
2022	2	0
2024	2	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K991441, 1994–2026Source: 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 KNG? 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 KNG device

#1 K252669 Fetal Doppler U8-25, U9-25score 13.0 · 9 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
*	K930200	Multi Dopplex II / Fetal Dopplex II Summary page 2 …Incorporated 38875 Cherry Street Newark, California Models FP3B and BF4B, Preamendment devices Huntleigh Technologies Manalapan, New Jersey Dopplex II Pocket Doppler K930200, Cleared 6/24/94 81 Or 81 & C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service f, ulaury Food and D…	Huntleigh Healthcare, Inc.	1994	—
*	—	Medasonics Incorporated Models FP3B and BF4B Named without a submission number			—

Also cleared against K930200: 4 other devices →

What descends from it? (44)

See all 44

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

Number	Device	Applicant	Decided	Descendants
K024197	Lifedop Doppler	Summit Doppler Systems, Inc.	2003	31
K040480	Sonotrax Ultrasonic Pocket Doppler	Edan Instruments, Inc.	2004	21
K030466	Handydop	Elcat, GmbH	2003	1
K023143	Echo Sounder, ES-102EX	Koven Technology, Inc.	2002	1
K033156	OB1 Obstetrical Doppler	D. E. Hokanson, Inc.	2003	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, K024197 (Summit Doppler Systems, Inc., 2003) has gone furthest, with 31 descendants of its own.
4 other devices also cite its predicate K930200.

How does its category compare?

All KNG devices

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

FDA decisions per year · KNG

1in 2025

2007high 5 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNG

202in 2019

2007high 202 (2019) · low 57 (2011)2026

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

Recalls per year · KNG

No recall names KNG since 2007.

Adverse event reports per year · KNG

1in 2025

2007high 8 (2018) · low 0 (2007)2025

MAUDE reports naming product code KNG, 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	0	—	0
2008	1	—	2
2009	3	181	0
2010	2	—	0
2011	5	57	0
2012	0	—	0
2013	0	—	1
2014	1	—	1
2015	1	—	0
2016	1	—	0
2017	0	—	3
2018	3	154	8
2019	3	202	1
2020	0	—	2
2021	1	—	1
2022	2	—	0
2023	0	—	2
2024	2	—	3
2025	1	—	1
2026	1	—	—

What is it indicated for?

Using the 2.3 MHz probe:

Early detection of fetal life, detection of multiple pregnancies, fetal screening from early gestation through delivery, general indication of fetal well being.

Using the 5.1 Mhz probe:

Detection of blood flow in the peripheral vascular system of the body

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/K991441 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991441: Cadence Doppler Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991441

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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