510(k) · Cleared

Cleared

CorSens

K160656510(k) TraditionalCleared Nov 21, 2016258-day reviewClass II21 CFR 870.2320

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Corsens Medical, Ltd. · DXR Ballistocardiograph

Cleared on Nov 21, 2016 as substantially equivalent to K081603 (Heartforce Medical, Inc., 2009) after a 258-day review. Its family tree reaches back 2 generations to 1992.

Decided: Nov 21, 2016
Review: 258 days
Class: Class II
Product code: DXR
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K910994 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK910994 Modified SeismocardiographSeismed Instruments, Inc. · 1992
1 generation backK081603 Digital Ballistocardiograph, Model DGB 300Heartforce Medical, Inc. · 2009
This deviceK160656 CorSensCorsens Medical, Ltd. · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K910994	Modified Seismocardiograph	Seismed Instruments, Inc.	1992	—
−1	K081603	Digital Ballistocardiograph, Model DGB 300	Heartforce Medical, Inc.	2009	—
0 (this device)	K160656	CorSens	Corsens Medical, Ltd.	2016	—

FIG. 1 — Lineage of K160656, 1992–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K081603	Digital Ballistocardiograph, Model DGB 300 Summary page 5 …The CorSens device is substantially equivalent to the following market- cleared device: • dBG 300 Digital Ballistocardiograph (K081603) in respect to intended use, clinical indication and technologica…	Heartforce Medical, Inc.	2009	—
†	K142827	Visi Mobile Monitoring System, Visi Mobile Chest Sensor	Sotera Wireless, Inc.	2015	—
†	K073630	Modification to: Bpcard, Model Z-7000-0700	Qrs Diagnostic, LLC	2008	—

Also cleared against K081603: 2 other devices →

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 24 years and passes through 3 companies; a new generation was cleared every 17.5 years on median.
None of the 2 ancestors has a recall.
2 other devices also cite its predicate K081603.

How does its category compare?

All DXR devices

DXR Ballistocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · DXR

1in 2025

2007high 1 (2009) · low 0 (2007)2026

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	1	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	1	—	0
2026	0	—	—

What is it indicated for?

CorSens Device records vibrational waveforms produced by the heart contractions and transmitted to the chest wall.

CorSens Device may be used as a tool to measure the timing of part of the events in the cardiac cycle for adult population.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K160656 · printed Nov 6, 2026

Cite this page

510(k) Report. “K160656: CorSens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160656

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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