510(k) · Cleared
ClearedModified Seismocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seismed Instruments, Inc. · DSB Plethysmograph, Impedance
Cleared on Jan 15, 1992 after a 318-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jan 15, 1992
- Review
- 318 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK910994 Modified SeismocardiographSeismed Instruments, Inc. · 1992
- Descendant · cites it directly · 4 of its ownK081603 Digital Ballistocardiograph, Model DGB 300Heartforce Medical, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK143432 Cardio-TriTestCardio-Phoenix, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK243566 CardioTag™Cardiosense, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK182790 Cardio-TriTest v6.5Cardio-Phoenix, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK160656 CorSensCorsens Medical, Ltd. · 2016
Most influential descendants
Showing 5 of 5 · See all- K081603Digital Ballistocardiograph, Model DGB 300Heartforce Medical, Inc. · 2009 · cites it directly4descendants
- K143432Cardio-TriTestCardio-Phoenix, Inc. · 2015 · 2 generations on1descendant
- K243566CardioTag™Cardiosense, Inc. · 2025 · 2 generations on0descendants
- K182790Cardio-TriTest v6.5Cardio-Phoenix, Inc. · 2018 · 3 generations on0descendants
- K160656CorSensCorsens Medical, Ltd. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910994 | Modified Seismocardiograph | Seismed Instruments, Inc. | 1992 | — |
| +1 | K081603 | Digital Ballistocardiograph, Model DGB 300 | Heartforce Medical, Inc. | 2009 | — |
| +2 | K143432 | Cardio-TriTest | Cardio-Phoenix, Inc. | 2015 | — |
| +2 | K243566 | CardioTag™ | Cardiosense, Inc. | 2025 | — |
| +3 | K182790 | Cardio-TriTest v6.5 | Cardio-Phoenix, Inc. | 2018 | — |
| +2 | K160656 | CorSens | Corsens Medical, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DSB? 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 DSB device
- #1 K232089 SOZO Proscore 14.6 · 9 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081603 | Digital Ballistocardiograph, Model DGB 300 | 2009 | 4 |
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?
- Of its descendants, K081603 (Heartforce Medical, Inc., 2009) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DSB devicesDSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSB
266in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSB
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSB
2in 2025
MAUDE reports naming product code DSB, 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 | 2 | — | 0 | 0 |
| 2008 | 6 | 90 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 266 | 0 | 2 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K910994 · printed Nov 3, 2026
Cite this page
510(k) Report. “K910994: Modified Seismocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K910994
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026