510(k) · Cleared

Cleared

Model 116 Fetal Monitor

K891595510(k) TraditionalCleared Jun 12, 198984-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 Jun 12, 1989 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.

Decided: Jun 12, 1989
Review: 84 days
Class: Class II
Product code: HGM
Recalls: None
Predicates: 0

7 later devices descend from it, 4 citing it directly.

This deviceK891595 Model 116 Fetal MonitorGe Medical Systems Information Technologies · 1989
Descendant · cites it directly · 3 of its ownK982651 Corometrics Model 5700 and 2264 Watertight TransducerCorometrics Medical Systems, Inc. · 1998
Descendant · cites it directly · 2 of its ownK992811 Transducers for Ultrasound and Tocodynamometer Fetal MonitoringEpic Medical Equipment Services, Inc. · 2000
Descendant · 2 generations on · 0 of its ownK061044 Featherlite Aqua TocodynamometerVentrex, Inc. · 2006
Descendant · cites it directly · 0 of its ownK050826 Fetal Ultrasound and Tocodynamometer TransducersCetro America · 2006
Descendant · cites it directly · 0 of its ownK043075 Tenacore Transducers for Fetal Ultrasonic and Tokodynamometer…Tenacore Holdings, Inc. · 2005

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1998high 2 (2004) · low 0 (1999)2026

Most influential descendants

Showing 5 of 7 · See all

K982651Corometrics Model 5700 and 2264 Watertight TransducerCorometrics Medical Systems, Inc. · 1998 · cites it directly3descendants
K992811Transducers for Ultrasound and Tocodynamometer Fetal MonitoringEpic Medical Equipment Services, Inc. · 2000 · cites it directly2descendants
K061044Featherlite Aqua TocodynamometerVentrex, Inc. · 2006 · 2 generations on0descendants
K050826Fetal Ultrasound and Tocodynamometer TransducersCetro America · 2006 · cites it directly0descendants
K043075Tenacore Transducers for Fetal Ultrasonic and Tokodynamometer MonitoringTenacore Holdings, Inc. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K891595	Model 116 Fetal Monitor	Ge Medical Systems Information Technologies	1989	—
+1	K982651	Corometrics Model 5700 and 2264 Watertight Transducer	Corometrics Medical Systems, Inc.	1998	—
+1	K992811	Transducers for Ultrasound and Tocodynamometer Fetal Monitoring	Epic Medical Equipment Services, Inc.	2000	—
+2	K061044	Featherlite Aqua Tocodynamometer	Ventrex, Inc.	2006	—
+1	K050826	Fetal Ultrasound and Tocodynamometer Transducers	Cetro America	2006	—
+1	K043075	Tenacore Transducers for Fetal Ultrasonic and Tokodynamometer Monitoring	Tenacore Holdings, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2000	1	0
2004	2	0
2005	1	0
2006	2	0

FIG. 1 — Lineage of K891595, 1989–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K982651	Corometrics Model 5700 and 2264 Watertight Transducer	Corometrics Medical Systems, Inc.	1998	3
K992811	Transducers for Ultrasound and Tocodynamometer Fetal Monitoring	Epic Medical Equipment Services, Inc.	2000	2
K050826	Fetal Ultrasound and Tocodynamometer Transducers	Cetro America	2006	0
K043075	Tenacore Transducers for Fetal Ultrasonic and Tokodynamometer Monitoring	Tenacore Holdings, Inc.	2005	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?

Of its descendants, K982651 (Corometrics Medical Systems, Inc., 1998) has gone furthest, with 3 descendants of its own.

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	—

https://510kreport.com/device/K891595 · printed Nov 5, 2026

Cite this page

510(k) Report. “K891595: Model 116 Fetal Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K891595

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026