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
Epic Medical Equipment Services, Inc. · HFM Monitor, Uterine Contraction, External (For Use In Clinic)
Cleared on Jan 18, 2000 as substantially equivalent to K843385 (Ge Medical Systems Information Technologies, 1984) and 4 other predicates after a 151-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it.
- Decided
- Jan 18, 2000
- Review
- 151 days
- Class
- Class II
- Product code
- HFM
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K911310 (1991). 6 ancestors in all, the oldest K843385 (1984). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK911310 Corometrics 5566AAX Noninvasive Blood Pressure ModGe Medical Systems Information Technologies · 1991 · Recalled
- 1 generation backK964770 Corometrics 120 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies · 1997
- This deviceK992811 Transducers for Ultrasound and Tocodynamometer Fetal MonitoringEpic Medical Equipment Services, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK043075 Tenacore Transducers for Fetal Ultrasonic and Tokodynamometer…Tenacore Holdings, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK040392 Transducers for Ultrasound and Tocodynamometer Fetal MonitoringAmerican I.V. Products, Inc. · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911310 | Corometrics 5566AAX Noninvasive Blood Pressure Mod | Ge Medical Systems Information Technologies | 1991 | 1 |
| −1 | K964770 | Corometrics 120 Series Maternal/Fetal Monitor | Ge Medical Systems Information Technologies | 1997 | — |
| 0 (this device) | K992811 | Transducers for Ultrasound and Tocodynamometer Fetal Monitoring | Epic Medical Equipment Services, Inc. | 2000 | — |
| +1 | K043075 | Tenacore Transducers for Fetal Ultrasonic and Tokodynamometer Monitoring | Tenacore Holdings, Inc. | 2005 | — |
| +1 | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 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? (6)
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 |
|---|---|---|---|
| * | K843385 | Corometrics 115 Fetal MonitorSummary page 1…eter fetal monitoring Predicate Device: These devices are equivalent to the following legally-marketed devices: Corometrics Models FM (US & TOCO) 115 (5600 & 2260) — K843385 116 (5700 & 2260) — K891595 118 (5700 & 2260) — K934959 120 (5700 & 2260) — K964770 Hewlett Packard Models 8040 (15245 & 15248)… | 1984 |
| * | K891595 | Model 116 Fetal MonitorSummary page 1…cate Device: These devices are equivalent to the following legally-marketed devices: Corometrics Models FM (US & TOCO) 115 (5600 & 2260) — K843385 116 (5700 & 2260) — K891595 118 (5700 & 2260) — K934959 120 (5700 & 2260) — K964770 Hewlett Packard Models 8040 (15245 & 15248) — 510(k) unknown 1350 (1356… | 1989 |
| * | K934959 | Model 118 Fetal/Maternal MonitorSummary page 1…are equivalent to the following legally-marketed devices: Corometrics Models FM (US & TOCO) 115 (5600 & 2260) — K843385 116 (5700 & 2260) — K891595 118 (5700 & 2260) — K934959 120 (5700 & 2260) — K964770 Hewlett Packard Models 8040 (15245 & 15248) — 510(k) unknown 1350 (1356 & 1355) — K900480 Descripti… | 1994 |
| * | K964770 | Corometrics 120 Series Maternal/Fetal MonitorSummary page 1…ing legally-marketed devices: Corometrics Models FM (US & TOCO) 115 (5600 & 2260) — K843385 116 (5700 & 2260) — K891595 118 (5700 & 2260) — K934959 120 (5700 & 2260) — K964770 Hewlett Packard Models 8040 (15245 & 15248) — 510(k) unknown 1350 (1356 & 1355) — K900480 Description: Epic’s ultrasound and t… | 1997 |
| * | K900480 | M1350A Fetal Monitor (Intrapartum)Summary page 1…85 116 (5700 & 2260) — K891595 118 (5700 & 2260) — K934959 120 (5700 & 2260) — K964770 Hewlett Packard Models 8040 (15245 & 15248) — 510(k) unknown 1350 (1356 & 1355) — K900480 Description: Epic’s ultrasound and tocodynamometer (toco) transducers are replacements for similar transducers manufactured by… | 1990 |
| * | — | Hewlett Packard Model 8040 (15245 & 15248) Named without a submission number |
What descends from it? (2)
2 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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K043075 (Tenacore Holdings, Inc., 2005) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K843385.
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 for use as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient.
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/K992811 · printed Nov 3, 2026
Cite this page
510(k) Report. “K992811: 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/K992811
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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