510(k) · Cleared
ClearedCmi Magnetocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cmi Cardiomag Imaging, Inc. · DPS Electrocardiograph
Cleared on Jul 7, 2004 as substantially equivalent to K760542 (Hewlett-Packard Co., 1976) and 1 other predicate after a 246-day review. Its family tree reaches back 2 generations to 1990. 5 later devices descend from it.
- Decided
- Jul 7, 2004
- Review
- 246 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K901215 (1990). 3 ancestors in all, the oldest K760542 (1976). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK901215 700 Series BiomagnetometerBiomagnetic Technologies, Inc. · 1990
- 1 generation backK962764 Neuromag-122Philips Medical Systems (Cleveland), Inc. · 1996
- This deviceK033488 Cmi MagnetocardiographCmi Cardiomag Imaging, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK151135 Model 621/624 BiomagnetometerTristan Technologies, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK121825 CS-Mag IIBiomagnetik-Park GmbH · 2013
- Descendant · 2 generations on · 0 of its ownK232823 MCG-S (AM1000)Amcg Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK182571 CardioFlux with Faraday Analytical CloudGenetesis, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK170154 Creavo Vitalscan MagnetocardiographCreavo Medical Technologies, Ltd. · 2017
Most influential descendants
Showing 5 of 5 · See all- K151135Model 621/624 BiomagnetometerTristan Technologies, Inc. · 2016 · cites it directly1descendant
- K121825CS-Mag IIBiomagnetik-Park GmbH · 2013 · cites it directly1descendant
- K232823MCG-S (AM1000)Amcg Co., Ltd. · 2024 · 2 generations on0descendants
- K182571CardioFlux with Faraday Analytical CloudGenetesis, Inc. · 2019 · 2 generations on0descendants
- K170154Creavo Vitalscan MagnetocardiographCreavo Medical Technologies, Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901215 | 700 Series Biomagnetometer | Biomagnetic Technologies, Inc. | 1990 | — |
| −1 | K962764 | Neuromag-122 | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| 0 (this device) | K033488 | Cmi Magnetocardiograph | Cmi Cardiomag Imaging, Inc. | 2004 | — |
| +1 | K151135 | Model 621/624 Biomagnetometer | Tristan Technologies, Inc. | 2016 | — |
| +1 | K121825 | CS-Mag II | Biomagnetik-Park GmbH | 2013 | — |
| +2 | K232823 | MCG-S (AM1000) | Amcg Co., Ltd. | 2024 | — |
| +2 | K182571 | CardioFlux with Faraday Analytical Cloud | Genetesis, Inc. | 2019 | — |
| +1 | K170154 | Creavo Vitalscan Magnetocardiograph | Creavo Medical Technologies, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K760542 | Electrocardiograph (#1505A)Summary page 1…ame: magnetocardiograph Classification Name: to be determined 3. PREDICATE DEVICES Hewlett Packard, model 151 lB ECG K760542 Neuromag-122 magnetoencephalograph K962764 4. DEVICE DESCRIPTION This device… | 1976 |
| * | K962764 | Neuromag-122Summary page 1…CATE DEVICES Hewlett Packard, model 151 lB ECG K760542 Neuromag-122 magnetoencephalograph K962764 4. DEVICE DESCRIPTION This device integrates an array of magnetic detectors with data acquisition hardware/so… | 1996 |
What descends from it? (5)
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K151135 (Tristan Technologies, Inc., 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 CMI Magnetocardiograph is intended for use as a tool that non-invasively measures
and displays the magnetic signals produced by the electric currents in the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033488 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033488: Cmi Magnetocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033488
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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