510(k) · Cleared

Cleared

Corometrics 120 Series Maternal/Fetal Monitor

K964770510(k) TraditionalCleared Feb 21, 199786-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

Ge Medical Systems Information Technologies · HGM System, Monitoring, Perinatal

Cleared on Feb 21, 1997 as substantially equivalent to K934959 (Ge Medical Systems Information Technologies, 1994) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1991. 16 later devices descend from it.

Decided: Feb 21, 1997
Review: 86 days
Class: Class II
Product code: HGM
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K911310 (1991). 2 ancestors in all. 16 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK911310 Corometrics 5566AAX Noninvasive Blood Pressure ModGe Medical Systems Information Technologies · 1991 · Recalled
This deviceK964770 Corometrics 120 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies · 1997
Descendant · cites it directly · 10 of its ownK991739 Corometrics 120 Series Maternal/Fetal MonitorGeneral Electric Medical Systems Information Techn · 1999
Descendant · 2 generations on · 6 of its ownK082602 Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc. · 2008
Descendant · 2 generations on · 5 of its ownK100797 Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc. · 2010
Descendant · 3 generations on · 2 of its ownK150901 Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 ExpressEdan Instruments, Inc. · 2015 · Recalled
Descendant · 2 generations on · 2 of its ownK032252 Model 120 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies · 2003

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

1999high 2 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 16 · See all

K991739Corometrics 120 Series Maternal/Fetal MonitorGeneral Electric Medical Systems Information Techn · 1999 · cites it directly10descendants
K082602Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc. · 2008 · 2 generations on6descendants
K100797Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc. · 2010 · 2 generations on5descendants
K150901Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 ExpressEdan Instruments, Inc. · 2015 · 3 generations on2descendants
K032252Model 120 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies · 2003 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K911310	Corometrics 5566AAX Noninvasive Blood Pressure Mod	Ge Medical Systems Information Technologies	1991	1
0 (this device)	K964770	Corometrics 120 Series Maternal/Fetal Monitor	Ge Medical Systems Information Technologies	1997	—
+1	K991739	Corometrics 120 Series Maternal/Fetal Monitor	General Electric Medical Systems Information Techn	1999	—
+2	K082602	Fetal & Maternal Monitor, Model F6, F9	Edan Instruments, Inc.	2008	—
+2	K100797	Fetal Maternal Monitor Model F9 Express and Express	Edan Instruments, Inc.	2010	—
+3	K150901	Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express	Edan Instruments, Inc.	2015	1
+2	K032252	Model 120 Series Maternal/Fetal Monitor	Ge Medical Systems Information Technologies	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2000	1	0
2001	1	0
2002	1	0
2003	1	0
2004	1	0
2005	2	0
2007	1	0
2008	1	0
2010	1	0
2011	1	0
2014	1	0
2015	1	0
2018	1	0
2025	1	0

FIG. 1 — Lineage of K964770, 1991–2025Source: 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

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
*	K934959	Model 118 Fetal/Maternal Monitor Summary page 1 …fication of Legally Marketed Equivalent Devices (Predicate Systems). Predicate System \| _Manufgeturer , k Number Model 118 Maternal/ \| Corometrics Medical Systems, Inc. k934959, clearance Fetal Monitor 61 Barnes Park Road North date: 10/15/94 Model 556 Critical Wallingford, CT 06492 k911310, clearance Car…	Ge Medical Systems Information Technologies	1994	—
*	K911310	Corometrics 5566AAX Noninvasive Blood Pressure Mod Summary page 1 …odel 118 Maternal/ \| Corometrics Medical Systems, Inc. k934959, clearance Fetal Monitor 61 Barnes Park Road North date: 10/15/94 Model 556 Critical Wallingford, CT 06492 k911310, clearance Care Monitor date: 6/10/91 [807.92(a)4 & 807.92(a)5] Device Description & Intended Use The 120 Series is intended fo…	Ge Medical Systems Information Technologies	1991	1

Also cleared against K934959: 3 other devices →

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K991739	Corometrics 120 Series Maternal/Fetal Monitor	General Electric Medical Systems Information Techn	1999	10
K992811	Transducers for Ultrasound and Tocodynamometer Fetal Monitoring	Epic Medical Equipment Services, Inc.	2000	2
K012718	Modification to Corometrics Model 120IS Maternal/Fetal Monitoring System.	Ge Medical Systems Information Technologies	2001	1

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K991739 (General Electric Medical Systems Information Techn, 1999) has gone furthest, with 10 descendants of its own.
3 other devices also cite its predicate K934959.

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 120 Series is intended for monitoring fetal and maternal vital signs: fetal heart rate; and maternal uterine activity, heart/pulse rate, blood pressure, and %Sp07. The device is intended for use in a hospital/clinical environment.

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/K964770 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964770: Corometrics 120 Series Maternal/Fetal Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964770

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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