510(k) · Cleared
ClearedCorometrics Model 5700 and 2264 Watertight Transducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corometrics Medical Systems, Inc. · HEL Monitor, Heart Rate, Fetal, Ultrasonic
Cleared on Dec 11, 1998 as substantially equivalent to K891595 (Ge Medical Systems Information Technologies, 1989) and 1 other predicate after a 134-day review. Its family tree reaches back 1 generation to 1989. 3 later devices descend from it.
- Decided
- Dec 11, 1998
- Review
- 134 days
- Class
- Class II
- Product code
- HEL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K891595 (1989). 2 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK891595 Model 116 Fetal MonitorGe Medical Systems Information Technologies · 1989
- This deviceK982651 Corometrics Model 5700 and 2264 Watertight TransducerCorometrics Medical Systems, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK061044 Featherlite Aqua TocodynamometerVentrex, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK040392 Transducers for Ultrasound and Tocodynamometer Fetal MonitoringAmerican I.V. Products, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK040819 Transducer for Ultrasound Fetal Monitoring, Models FM10833 and FM10834American I.V. Products, Inc. · 2004
Most influential descendants
Showing 3 of 3 · See all- K061044Featherlite Aqua TocodynamometerVentrex, Inc. · 2006 · cites it directly0descendants
- K040392Transducers for Ultrasound and Tocodynamometer Fetal MonitoringAmerican I.V. Products, Inc. · 2004 · cites it directly0descendants
- K040819Transducer for Ultrasound Fetal Monitoring, Models FM10833 and FM10834American I.V. Products, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891595 | Model 116 Fetal Monitor | Ge Medical Systems Information Technologies | 1989 | — |
| 0 (this device) | K982651 | Corometrics Model 5700 and 2264 Watertight Transducer | Corometrics Medical Systems, Inc. | 1998 | — |
| +1 | K061044 | Featherlite Aqua Tocodynamometer | Ventrex, Inc. | 2006 | — |
| +1 | K040392 | Transducers for Ultrasound and Tocodynamometer Fetal Monitoring | American I.V. Products, Inc. | 2004 | — |
| +1 | K040819 | Transducer for Ultrasound Fetal Monitoring, Models FM10833 and FM10834 | American I.V. Products, Inc. | 2004 | — |
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 |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 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 HEL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 MonitorSummary page 1…[ 807.92(a)3 ] Identification of Legally Marketed Equivalent Devices (Predicate Systems). Predicate System Manufacturer K Number Class Model 5700 US Corometrics Medical k891595 11 Transducer Systems, Inc. M1356A US Watertight Hewlett Packard K942887 1I Transducer Predicate System Manufacturer K Number Cla… | 1989 |
| * | K942887 | Model M1310A, Series 50T Fetal Telemetry SystemSummary page 1…dicate Systems). Predicate System Manufacturer K Number Class Model 5700 US Corometrics Medical k891595 11 Transducer Systems, Inc. M1356A US Watertight Hewlett Packard K942887 1I Transducer Predicate System Manufacturer K Number Class Model 2260 Toco Corometrics Medical k891595 IT Transducer Systems, Inc… | 1994 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All HEL devicesHEL Monitor, Heart Rate, Fetal, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HEL
FDA has decided no HEL device since 2007.
Median 510(k) review, days · HEL
Too few HEL 510(k)s in any year since 2007 to give a median.
Recalls per year · HEL
No recall names HEL since 2007.
Adverse event reports per year · HEL
1in 2025
MAUDE reports naming product code HEL, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Use of the Model 5700 and 2264 Series Non-Invasive Watertight Transducers are indicated as accessories to Corometrics Fetal and Fetal/Maternal Monitors. The Model 5700 Watertight Transducer provides for the detection of fetal heart rate and the Model 2264 Watertight Transducer provides for the detection of uterine activity. Both transducers are intended to be used in either water or non-water environments. When used in water environment applications both…
Read the full statement (122 words)
Use of the Model 5700 and 2264 Series Non-Invasive Watertight Transducers are indicated as accessories to Corometrics Fetal and Fetal/Maternal Monitors. The Model 5700 Watertight Transducer provides for the detection of fetal heart rate and the Model 2264 Watertight Transducer provides for the detection of uterine activity. Both transducers are intended to be used in either water or non-water environments. When used in water environment applications both transducers are intended to be directly connected to telemetry and not directly connected to a Fetal or Fetal /Maternal monitor or any AC powered monitoring devices. Labeling and labels, on the transducers themselves, instruct the care provider to directly connect the transducers to a telemetry system when the devices are exposed to a water 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/K982651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982651: Corometrics Model 5700 and 2264 Watertight Transducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982651
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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