510(k) · Cleared
ClearedCardiac Trigger Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivy Biomedical Systems, Inc. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on May 17, 2017 after a 58-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 17, 2017
- Review
- 58 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRT? 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 DRT device
- #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All DRT devicesDRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DRT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRT
228in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRT
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRT
40in 2025
MAUDE reports naming product code DRT, 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 | 1 | — | 0 | 113 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 6 | 70 | 0 | 118 |
| 2010 | 3 | 44 | 0 | 63 |
| 2011 | 3 | 149 | 1 | 36 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 48 |
| 2016 | 1 | — | 0 | 55 |
| 2017 | 1 | — | 0 | 159 |
| 2018 | 1 | — | 0 | 224 |
| 2019 | 1 | — | 0 | 447 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 2 | — | 1 | 85 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 3 | 228 | 1 | 29 |
| 2025 | 1 | — | 0 | 40 |
| 2026 | 5 | 120 | 0 | — |
What is it indicated for?
The Ivy Biomedical Model 7600, 7800 is a basic cardiac monitor used to provide cardiac trigger pulse outputs used by third-party systems that require ECG synchronization. Cardiac synchronization is commonly used in diagnostic imaging modalities (i.e., nuclear medicine, computed axial (CAT), or positron emission (PET) tomography) or other applications requiring such synchronization. The Model 7600/7800 is intended for use in neonatal, pediatric and adult…
Read the full statement (190 words)
The Ivy Biomedical Model 7600, 7800 is a basic cardiac monitor used to provide cardiac trigger pulse outputs used by third-party systems that require ECG synchronization. Cardiac synchronization is commonly used in diagnostic imaging modalities (i.e., nuclear medicine, computed axial (CAT), or positron emission (PET) tomography) or other applications requiring such synchronization.
The Model 7600/7800 is intended for use in neonatal, pediatric and adult patients undergoing diagnostic imaging and related procedures in inpatient and outpatient centers under the supervision of licensed healthcare professionals.
The product is not intended for use as a life support, home monitoring, or magnetic resonance imaging (MRI) modality.
Patient Population
The Model 7600/7800 Cardiac Trigger Monitor is intended to perform ECG monitoring and R-wave pulse detection on adult, geriatric, pediatric and neonatal patients. R-wave synchronization is typically used for gating nuclear scanners, CT scanners, or other imaging devices.
Contraindications
The Model 7600/7800 is limited to use by trained and qualified medical professionals. This device is not intended for use as a life support or for performing cardiac diagnosis. The product is not intended for use in home care monitoring or for use in an MRI environment.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K170828 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170828: Cardiac Trigger Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170828
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026