510(k) · Cleared
ClearedTenacore Transducers for Fetal Ultrasonic and Tokodynamometer Monitoring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tenacore Holdings, Inc. · HGM System, Monitoring, Perinatal
Cleared on Aug 18, 2005 as substantially equivalent to K891595 (Ge Medical Systems Information Technologies, 1989) and 1 other predicate after a 283-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Aug 18, 2005
- Review
- 283 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K911310 (1991). 7 ancestors in all, the oldest K843385 (1984). No later device cites it as a predicate yet.
- Root · 3 generations backK911310 Corometrics 5566AAX Noninvasive Blood Pressure ModGe Medical Systems Information Technologies · 1991 · Recalled
- 2 generations backK964770 Corometrics 120 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies · 1997
- 1 generation backK992811 Transducers for Ultrasound and Tocodynamometer Fetal MonitoringEpic Medical Equipment Services, Inc. · 2000
- This deviceK043075 Tenacore Transducers for Fetal Ultrasonic and Tokodynamometer…Tenacore Holdings, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911310 | Corometrics 5566AAX Noninvasive Blood Pressure Mod | Ge Medical Systems Information Technologies | 1991 | 1 |
| −2 | K964770 | Corometrics 120 Series Maternal/Fetal Monitor | Ge Medical Systems Information Technologies | 1997 | — |
| −1 | K992811 | Transducers for Ultrasound and Tocodynamometer Fetal Monitoring | Epic Medical Equipment Services, Inc. | 2000 | — |
| 0 (this device) | K043075 | Tenacore Transducers for Fetal Ultrasonic and Tokodynamometer Monitoring | Tenacore Holdings, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K891595 | Model 116 Fetal Monitor | 1989 |
| * | K992811 | Transducers for Ultrasound and Tocodynamometer Fetal MonitoringSummary page 1…Corometrics 116 (5700 & 2260), 510 (k) # K891S95 by GE Marquette Medical Systems b. Epic's transducer, 510(k) #992811 by Epic Medical Equipment Services. Description: Tenacore Holdings, Inc. Transducers for Fetal Ultrasound and Tokodynamome… | 2000 |
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 14 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 3 other devices also cite its predicate K891595.
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HGM
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HGM
269in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HGM
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HGM
99in 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?
These transducers are intended to be used as replacement accessories for
Hewlett Packard and Corometrics fetal monitors. These transducers measure
fetal heart rate or uterine contractions in the gravid patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043075 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043075: Tenacore Transducers for Fetal Ultrasonic and Tokodynamometer Monitoring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043075
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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