510(k) · Cleared
ClearedDigital Ballistocardiograph, Model DGB 300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartforce Medical, Inc. · DXR Ballistocardiograph
Cleared on Jul 24, 2009 as substantially equivalent to K910994 (Seismed Instruments, Inc., 1992) after a 413-day review. Its family tree reaches back 1 generation to 1992. 4 later devices descend from it.
- Decided
- Jul 24, 2009
- Review
- 413 days
- Class
- Class II
- Product code
- DXR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910994 (1992). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK910994 Modified SeismocardiographSeismed Instruments, Inc. · 1992
- This deviceK081603 Digital Ballistocardiograph, Model DGB 300Heartforce Medical, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK143432 Cardio-TriTestCardio-Phoenix, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK243566 CardioTag™Cardiosense, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK182790 Cardio-TriTest v6.5Cardio-Phoenix, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK160656 CorSensCorsens Medical, Ltd. · 2016
Most influential descendants
Showing 4 of 4 · See all- K143432Cardio-TriTestCardio-Phoenix, Inc. · 2015 · cites it directly1descendant
- K243566CardioTag™Cardiosense, Inc. · 2025 · cites it directly0descendants
- K182790Cardio-TriTest v6.5Cardio-Phoenix, Inc. · 2018 · 2 generations on0descendants
- K160656CorSensCorsens Medical, Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910994 | Modified Seismocardiograph | Seismed Instruments, Inc. | 1992 | — |
| 0 (this device) | K081603 | Digital Ballistocardiograph, Model DGB 300 | Heartforce Medical, Inc. | 2009 | — |
| +1 | K143432 | Cardio-TriTest | Cardio-Phoenix, Inc. | 2015 | — |
| +1 | K243566 | CardioTag™ | Cardiosense, Inc. | 2025 | — |
| +2 | K182790 | Cardio-TriTest v6.5 | Cardio-Phoenix, Inc. | 2018 | — |
| +1 | K160656 | CorSens | Corsens Medical, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 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 DXR? 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 DXR device
- #1 K243566 CardioTag™score 10.0 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K910994 | Modified SeismocardiographSummary page 1…ECG signal and with a suitable miniature electronic accelerometer for the mechanical motion. Predicate Device: K910994 Modified Seismocardiograph - Seismed Instruments, Inc Substantial Equivalence: Heart Force cla… | 1992 |
What descends from it? (4)
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?
- Its one ancestor has no recall.
- Of its descendants, K143432 (Cardio-Phoenix, Inc., 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DXR devicesDXR Ballistocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DXR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXR
Too few DXR 510(k)s in any year since 2007 to give a median.
Recalls per year · DXR
No recall names DXR since 2007.
Adverse event reports per year · DXR
No MAUDE report names DXR since 2007.
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 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The dBG 300 records vibrational waveforms produced by the hearts contractions and transmitted to the chest wall. The dBG 300 may be used as a tool to measure the timing of the events in the cardiac cycle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081603 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081603: Digital Ballistocardiograph, Model DGB 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081603
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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