510(k) · Cleared
ClearedTransducers for Ultrasound and Tocodynamometer Fetal Monitoring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American I.V. Products, Inc. · HFM Monitor, Uterine Contraction, External (For Use In Clinic)
Cleared on Sep 14, 2004 as substantially equivalent to K982651 (Corometrics Medical Systems, Inc., 1998) and 1 other predicate after a 210-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Sep 14, 2004
- Review
- 210 days
- Class
- Class II
- Product code
- HFM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K911310 (1991). 9 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 deviceK040392 Transducers for Ultrasound and Tocodynamometer Fetal MonitoringAmerican I.V. Products, Inc. · 2004
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) | K040392 | Transducers for Ultrasound and Tocodynamometer Fetal Monitoring | American I.V. Products, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1998 | 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 HFM? 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 |
|---|---|---|---|
| * | K982651 | Corometrics Model 5700 and 2264 Watertight TransducerSummary page 6…FM10836 FM10841 Predicate Device: These AIV devices are equivalent to the following legally marketed devices: Corometrics Models 2264LAX (TOCO) K982651 5700LAX (Ultrasound) K982651 Epic Models EFT200-20 (TOCO) K992811 EFU200-20 (Ultrasound) K992811 Hewlett Packard Models 1355 TOCO… | 1998 |
| * | K992811 | Transducers for Ultrasound and Tocodynamometer Fetal MonitoringSummary page 4…Series 50 XM monitors. Additional Comments: This device is a direct replacement for the EPIC EFU200- 20 (and Hewlett Packard Model 1356, by Epic Substantial Equivalence K992811) Ultrasound Transducer for measuring fetal heart rate. %M%A;M (Division Sign-Off) Division of Reproductive, Abdominal, and Radi… | 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 13 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 2 other devices also cite its predicate K982651.
How does its category compare?
All HFM devicesHFM Monitor, Uterine Contraction, External (For Use In Clinic): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HFM
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · HFM
Too few HFM 510(k)s in any year since 2007 to give a median.
Recalls per year · HFM
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HFM
6in 2025
MAUDE reports naming product code HFM, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 2 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
These devices are intended to be used as replacement accessories to
Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and
uterine contractions in the gravid patient.
AlV Transducer Model Numbers: FM10835 and FM10836.
These devices are a direct replacement for the EPIC EFU200-20, Ultrasound Transducer for
measuring fetal heart rate.
AlV Transducer Model Numbers: FM10839 and FM10840.
These devices are a direct replacement for the Corometric's 2264L.AX, TOCO
Transducer for measuring uterine contractions.
AlV Transducer Model Number: FM10841.
This device is a direct replacement for the EPIC EFT200-20, TOCO Transducer for measuring
uterine contractions.
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/K040392 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040392: Transducers for Ultrasound and Tocodynamometer Fetal Monitoring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040392
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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