510(k) · Cleared
ClearedSpaulding IQ Electrocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spaulding Clinical Research, LLC · DPS Electrocardiograph
Cleared on Mar 2, 2011 as substantially equivalent to K093339 (Mortara Instrument, Inc., 2010) and 1 other predicate after a 51-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it.
- Decided
- Mar 2, 2011
- Review
- 51 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K942704 (1994). 9 ancestors in all, the oldest K933143 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK942704 Card Guard, Model CG-7000D Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 1994
- 3 generations backK993799 CG-7000DX Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 1999
- 2 generations backK052556 CG-7000DX-BT Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 2006
- 1 generation backK082077 BT3/6, BT12Corscience GmbH & Co. KG · 2008
- This deviceK110065 Spaulding IQ ElectrocardiographSpaulding Clinical Research, LLC · 2011
- Descendant · cites it directly · 1 of its ownK150564 Spaulding Electrocardiograph 2100iQSpaulding Clinical Research, LLC · 2015
- Descendant · 2 generations on · 0 of its ownK163607 ECG Acquisition SystemsVales & Hills Biomedical Tech., Ltd. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942704 | Card Guard, Model CG-7000D Ecg Recorder/Transmitter | Card Guard Scientific Survival, Ltd. | 1994 | — |
| −3 | K993799 | CG-7000DX Ecg Recorder/Transmitter | Card Guard Scientific Survival, Ltd. | 1999 | — |
| −2 | K052556 | CG-7000DX-BT Ecg Recorder/Transmitter | Card Guard Scientific Survival, Ltd. | 2006 | — |
| −1 | K082077 | BT3/6, BT12 | Corscience GmbH & Co. KG | 2008 | — |
| 0 (this device) | K110065 | Spaulding IQ Electrocardiograph | Spaulding Clinical Research, LLC | 2011 | — |
| +1 | K150564 | Spaulding Electrocardiograph 2100iQ | Spaulding Clinical Research, LLC | 2015 | — |
| +2 | K163607 | ECG Acquisition Systems | Vales & Hills Biomedical Tech., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 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 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 |
|---|---|---|---|
| * | K093339 | Eli PC ElectrocardiographSummary page 1…arch I0 Electrocardiograph is substantially equivalent to the legally marketed devices presently in distribution: * Mortara Instrument ELI PC Electrocardiograph (K093339) " Corscience GmbH &Co.KG, Corscience BT PC ECG Device (K082077) Description: The proposed Spaulding IQis an electrocardi… | 2010 |
| * | K082077 | BT3/6, BT12Summary page 1…rketed devices presently in distribution: * Mortara Instrument ELI PC Electrocardiograph (K093339) " Corscience GmbH &Co.KG, Corscience BT PC ECG Device (K082077) Description: The proposed Spaulding IQis an electrocardiograph that combines proprietary hardware, current industry technologies… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150564 | Spaulding Electrocardiograph 2100iQ | 2015 | 1 |
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 17 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K150564 (Spaulding Clinical Research, LLC, 2015) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K093339.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The IQ Electrocardiograph is a non-invasive prescription device that is indicated for use: * The proposed IQ Electrocardiograph is indicated for use to acquire, analyze, display and print electrocardiograms. * The device is indicated for use for pediatric and adult populations, diseased or non-diseased. The device is not indicated for use for neonatal (birth to 28 days) or infants (29 days up to 2 years). * The interpretations of ECG data offered by the…
Read the full statement (215 words)
The IQ Electrocardiograph is a non-invasive prescription device that is indicated for use:
* The proposed IQ Electrocardiograph is indicated for use to acquire, analyze, display and print electrocardiograms.
* The device is indicated for use for pediatric and adult populations, diseased or non-diseased. The device is not indicated for use for neonatal (birth to 28 days) or infants (29 days up to 2 years).
* The interpretations of ECG data offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.
* The device is indicated for use in a clinical setting, by qualified medical professionals, properly trained for EGG monitoring and use of the system. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements. It is not intended as a sole means of diagnosis.
* The device is not intended to be used as a vital signs physiological monitor.
* It is not designed for out of hospital transport.
* It is not designed for use in highly invasive environments, such as an operating theatre.
* The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110065 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110065: Spaulding IQ Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110065
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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