510(k) · Cleared

Cleared

Cadence, Models 2001 and 2002

K040903510(k) TraditionalCleared Sep 2, 2004148-day reviewClass II21 CFR 884.2740

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

Edan Instruments, Inc. · HGM System, Monitoring, Perinatal

Cleared on Sep 2, 2004 as substantially equivalent to K002150 (Oxford Instruments, 2001) and 1 other predicate after a 148-day review. Its family tree reaches back 2 generations to 1985. 12 later devices descend from it.

Decided: Sep 2, 2004
Review: 148 days
Class: Class II
Product code: HGM
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K852608 (1985). 4 ancestors in all. 12 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK852608 Spectra 400 Extended Surveillance & Alert SystemGe Medical Systems Information Technologies · 1985
1 generation backK991905 Corometrics Model 171 and 172 Fetal MonitorGeneral Electric Medical Systems Information Techn · 1999
This deviceK040903 Cadence, Models 2001 and 2002Edan Instruments, Inc. · 2004
Descendant · cites it directly · 11 of its ownK073221 Cadence IIEdan Instruments, Inc. · 2007
Descendant · 2 generations on · 6 of its ownK082602 Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc. · 2008
Descendant · 3 generations on · 5 of its ownK100797 Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc. · 2010
Descendant · cites it directly · 4 of its ownK082369 Cadence, Cadence Dual, Cadence II Fetal MonitorEdan Instruments, Inc. · 2008
Descendant · 2 generations on · 3 of its ownK102140 Fetal Monitors, Models F2 and F3Edan Instruments, Inc. · 2011 · Recalled

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2007high 3 (2011) · low 0 (2009)2026

Most influential descendants

Showing 5 of 12 · See all

K073221Cadence IIEdan Instruments, Inc. · 2007 · cites it directly11descendants
K082602Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc. · 2008 · 2 generations on6descendants
K100797Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc. · 2010 · 3 generations on5descendants
K082369Cadence, Cadence Dual, Cadence II Fetal MonitorEdan Instruments, Inc. · 2008 · cites it directly4descendants
K102140Fetal Monitors, Models F2 and F3Edan Instruments, Inc. · 2011 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K852608	Spectra 400 Extended Surveillance & Alert System	Ge Medical Systems Information Technologies	1985	—
−1	K991905	Corometrics Model 171 and 172 Fetal Monitor	General Electric Medical Systems Information Techn	1999	—
0 (this device)	K040903	Cadence, Models 2001 and 2002	Edan Instruments, Inc.	2004	—
+1	K073221	Cadence II	Edan Instruments, Inc.	2007	—
+2	K082602	Fetal & Maternal Monitor, Model F6, F9	Edan Instruments, Inc.	2008	—
+3	K100797	Fetal Maternal Monitor Model F9 Express and Express	Edan Instruments, Inc.	2010	—
+1	K082369	Cadence, Cadence Dual, Cadence II Fetal Monitor	Edan Instruments, Inc.	2008	—
+2	K102140	Fetal Monitors, Models F2 and F3	Edan Instruments, Inc.	2011	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	2	0
2010	1	0
2011	3	0
2014	2	0
2015	1	0
2018	1	0
2025	1	0

FIG. 1 — Lineage of K040903, 1985–2025Source: 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 HGM? 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 HGM device

#1 K241882 Fetal & Maternal Monitor (F15A, F15A Air)score 19.5 · 33 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? (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
*	K002150	Sonicaid FM820, Sonicaid FM830 Summary page 2 …SONICAID 820 COROMETRICS 171 2001,2002 AND 172 ATTRIBUTE 51 Ok Number k040903 k002150 k991905 Singleton yes yes yes (model 2001) Twins ye…	Oxford Instruments	2001	—
*	K991905	Corometrics Model 171 and 172 Fetal Monitor Summary page 2 …COROMETRICS 171 2001,2002 AND 172 ATTRIBUTE 51 Ok Number k040903 k002150 k991905 Singleton yes yes yes (model 2001) Twins yes…	General Electric Medical Systems Information Techn	1999	—

Also cleared against K002150: 1 other device →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K073221	Cadence II	Edan Instruments, Inc.	2007	11
K082369	Cadence, Cadence Dual, Cadence II Fetal Monitor	Edan Instruments, Inc.	2008	4

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 19 years and passes through 3 companies; a new generation was cleared every 13.9 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K073221 (Edan Instruments, Inc., 2007) has gone furthest, with 11 descendants of its own.
1 other device also cites its predicate K002150.

How does its category compare?

All HGM devices

HGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HGM

4in 2025

2007high 13 (2011) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HGM

269in 2025

2007high 269 (2025) · low 56 (2007)2026

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

Recalls per year · HGM

5in 2019

2007high 6 (2009) · low 0 (2007)2026

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

Adverse event reports per year · HGM

99in 2025

2007high 174 (2024) · low 16 (2013)2025

MAUDE reports naming product code HGM, 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	3	56	0	35
2008	4	75	4	17
2009	4	66	6	42
2010	4	193	0	64
2011	13	141	0	83
2012	4	107	0	44
2013	2	—	1	16
2014	4	231	1	30
2015	5	169	0	44
2016	1	—	0	17
2017	3	138	0	27
2018	3	258	0	30
2019	0	—	5	41
2020	1	—	0	19
2021	0	—	0	71
2022	1	—	0	87
2023	2	—	0	69
2024	1	—	0	174
2025	4	269	0	99
2026	2	—	2	—

What is it indicated for?

The Cadence Fetal Monitor, model 2001 for singletons and model 2002 for twins, is a fetal monitor for monitoring fetal well being during the antepartumn period. It performs what is commonly called the non stress test.

The Cadence Fetal Monitor 2001/2002 is to be used by trained medical personnel in hospitals clinics, physicians offices, and in the patients home by prescription or doctors orders.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040903 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040903: Cadence, Models 2001 and 2002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040903

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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