510(k) Report

510(k) · Cleared

Cleared

Fetal Ultrasound and Tocodynamometer Transducers

K050826510(k) TraditionalCleared Apr 10, 2006374-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

Cetro America · HGM System, Monitoring, Perinatal

Cleared on Apr 10, 2006 as substantially equivalent to K891595 (Ge Medical Systems Information Technologies, 1989) and 4 other predicates after a 374-day review. Its family tree reaches back 1 generation to 1985.

Decided
Apr 10, 2006
Review
374 days
Class
Class II
Product code
HGM
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K852076 (1985). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestor1990: 1 other ancestor1989: 1 other ancestor1985: 1 other ancestorK852076 · Model 145 Fetal Monitor · Ge Medical Systems Information Technologies · 198519851990199520002005
Other ancestors, by generation 1 generation back: 4 other ancestors K852076 · Model 145 Fetal Monitor · Ge Medical Systems Information Technologies · 19850
  1. Root · 1 generation backK852076 Model 145 Fetal MonitorGe Medical Systems Information Technologies · 1985
  2. This deviceK050826 Fetal Ultrasound and Tocodynamometer TransducersCetro America · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K852076Model 145 Fetal MonitorGe Medical Systems Information Technologies1985—
0 (this device)K050826Fetal Ultrasound and Tocodynamometer TransducersCetro America2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198910
199010
199510
FIG. 1 — Lineage of K050826, 1985–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241882 Fetal & Maternal Monitor (F15A, F15A Air)score 19.5 · 33 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K891595Model 116 Fetal Monitor
Summary page 2
…85 HGM Predicate Device Predicate Device: These devices are equivalent to the following legally marketed devices: * Corometrics 174 (U/S 5700 and TOCO 2260) K891595 * Corometrics 145 K852076 * HP 1356 (U/S 1356A and TOCO 1355A) K900480 * AMS IM-76 (U/S US91 and TO…
Ge Medical Systems Information Technologies1989—
*K852076Model 145 Fetal Monitor
Summary page 2
…Device: These devices are equivalent to the following legally marketed devices: * Corometrics 174 (U/S 5700 and TOCO 2260) K891595 * Corometrics 145 K852076 * HP 1356 (U/S 1356A and TOCO 1355A) K900480 * AMS IM-76 (U/S US91 and TOCO TD84) K852518 * AMS IM-…
Ge Medical Systems Information Technologies1985—
*K900480M1350A Fetal Monitor (Intrapartum)
Summary page 2
…legally marketed devices: * Corometrics 174 (U/S 5700 and TOCO 2260) K891595 * Corometrics 145 K852076 * HP 1356 (U/S 1356A and TOCO 1355A) K900480 * AMS IM-76 (U/S US91 and TOCO TD84) K852518 * AMS IM-77 (U/S US915 and TOCO TD84) K940898 Device Descriptio…
Hewlett-Packard Co.1990—
*K852518Modification Fetal Monitor Model FM-2
Summary page 2
…U/S 5700 and TOCO 2260) K891595 * Corometrics 145 K852076 * HP 1356 (U/S 1356A and TOCO 1355A) K900480 * AMS IM-76 (U/S US91 and TOCO TD84) K852518 * AMS IM-77 (U/S US915 and TOCO TD84) K940898 Device Description Cetro America, Inc. Transducers for Ultrasonic and…
Advantage Medical Systems, Inc.1985—
*K940898Model IM77 Intrapartum Fetal Monitor
Summary page 2
…145 K852076 * HP 1356 (U/S 1356A and TOCO 1355A) K900480 * AMS IM-76 (U/S US91 and TOCO TD84) K852518 * AMS IM-77 (U/S US915 and TOCO TD84) K940898 Device Description Cetro America, Inc. Transducers for Ultrasonic and Tocodynamometer fetal monitoring will be used as rep…
Advanced Medical Systems, Inc.1995—

Also cleared against K891595: 3 other devices →

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?

  • None of the 5 ancestors has a recall.
  • 3 other devices also cite its predicate K891595.

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

2007: 32008: 42009: 42010: 42011: 132012: 42013: 22014: 42015: 52016: 12017: 32018: 32020: 12022: 12023: 22024: 12025: 42026 (partial year): 2
2007high 13 (2011) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HGM

269in 2025

2007: 56 days median2008: 75 days median2009: 66 days median2010: 193 days median2011: 141 days median2012: 107 days median2014: 231 days median2015: 169 days median2017: 138 days median2018: 258 days median2025: 269 days median
2007high 269 (2025) · low 56 (2007)2026

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

Recalls per year · HGM

5in 2019

2008: 42009: 62013: 12014: 12019: 52026 (partial year): 2
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

2007: 352008: 172009: 422010: 642011: 832012: 442013: 162014: 302015: 442016: 172017: 272018: 302019: 412020: 192021: 712022: 872023: 692024: 1742025: 99
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007356035
2008475417
2009466642
20104193064
201113141083
20124107044
20132—116
20144231130
20155169044
20161—017
20173138027
20183258030
20190—541
20201—019
20210—071
20221—087
20232—069
20241—0174
20254269099
20262—2—

What is it indicated for?

These devices are replacement accessories for the original manufacturer's fetal monitor transducers and are intended to obtain signals to monitor and chart Fetal Heart Rate and maternal uterine activity on a fetal monitor.

Please refer to the chart below for appropriate replacement pairings:

Indications for use as stated in the FDA summary.

Also cleared against K891595

3 other devices cite the same predicate.

  • K043075Tenacore Transducers for Fetal Ultrasonic and Tokodynamometer MonitoringTenacore Holdings, Inc. · 2005
  • K992811Transducers for Ultrasound and Tocodynamometer Fetal MonitoringEpic Medical Equipment Services, Inc. · 2000
  • K982651Corometrics Model 5700 and 2264 Watertight TransducerCorometrics Medical Systems, Inc. · 1998

Recent decisions in HGM

The HGM category page

  • K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc. · 2026
  • K253021ANNE MaternalSibel Health, Inc. · 2026
  • K250777Sonicaid Team3Huntleigh Healthcare, Ltd. · 2025
  • K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc. · 2025
  • K241368Sonicaid Team3Huntleigh Healthcare, Ltd. · 2025

https://510kreport.com/device/K050826 · printed Nov 4, 2026

Cite this page

510(k) Report. “K050826: Fetal Ultrasound and Tocodynamometer Transducers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050826

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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