510(k) · Cleared
ClearedTransducer for Ultrasound Fetal Monitoring, Models FM10833 and FM10834
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American I.V. Products, Inc. · HGM System, Monitoring, Perinatal
Cleared on Aug 16, 2004 as substantially equivalent to K982651 (Corometrics Medical Systems, Inc., 1998) after a 139-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Aug 16, 2004
- Review
- 139 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K891595 (1989). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK891595 Model 116 Fetal MonitorGe Medical Systems Information Technologies · 1989
- 1 generation backK982651 Corometrics Model 5700 and 2264 Watertight TransducerCorometrics Medical Systems, Inc. · 1998
- This deviceK040819 Transducer for Ultrasound Fetal Monitoring, Models FM10833 and FM10834American I.V. Products, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K982651 | Corometrics Model 5700 and 2264 Watertight TransducerSummary page 1…s for ultrasound fetal monitoring Predicate Device: These AIV devices are equivalent to the following legally marketed devices: Corometrics Models 5700LAX (Ultrasound) K982651 Description: AIV's ultrasound (US) and tocodynamometer (TOCO) transducers are replacements for similar transducers manufactured… | 1998 |
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 15 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K982651.
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 devices are intended to be used as replacement accessories to Corometrics Monitors, to measure fetal heart rate in the gravid patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040819: Transducer for Ultrasound Fetal Monitoring, Models FM10833 and FM10834.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040819
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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