510(k) · Cleared
ClearedGem Heart One/One+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gem-Med S.L. · DPS Electrocardiograph
Cleared on Sep 4, 2009 after a 14-day review. The FDA summary names its predicate without a number.
- Decided
- Sep 4, 2009
- Review
- 14 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Cardioline AR 1200 Named without a submission number | |
| * | — | CorScreen Named without a submission number |
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 DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
Gem Heart One/One+ is a standard 12 leads electrocardiograph designed to register, analyze and display electrocardiograms at rest. It is capable of displaying up to 12 leads at a time on the screen and print 3/6 channels by means of its thermal printer of 112mm width. It incorporates the Hannover Electrocardiogram System (HES) automatic interpretation program for cardiac signal analysis and has the possibility of introducing the patient's data, store the…
Read the full statement (220 words)
Gem Heart One/One+ is a standard 12 leads electrocardiograph designed to register, analyze and display electrocardiograms at rest. It is capable of displaying up to 12 leads at a time on the screen and print 3/6 channels by means of its thermal printer of 112mm width.
It incorporates the Hannover Electrocardiogram System (HES) automatic interpretation program for cardiac signal analysis and has the possibility of introducing the patient's data, store the records and send them to a PC by serial communication (RS-232, USB and LAN). The interpretation by the Gem Heart One/One+ is only significant if it is considered and analysed by a qualified physician and used for patients over 16 years old. No therapy or drugs can be administered based solely on the interpretations statements obtained from the HES interpretation program.
For non-interpretative applications, the Gem Heart One/One+ can be used for patients with no limitations with respect to age, sex and race of the patient. It is intended for use in routine ECG recording by trained physicians in hospital environment.
* The Gem Heart One/One+ is a standard portable electrocardiograph that measures and records 12 channel electrocardiographic waveforms, measures ST segment level changes and gives real time heart rate measurements.
* Intended use is equivalent to the intended use of the predicate Cardioline AR 1200 and CorScreen electrocardiograph.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092576: Gem Heart One/One+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092576
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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