510(k) · Cleared
Recalled · 2010Cambridge Heart Micro-V Alternans Sensor, Model 20327-002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cambridge Heart, Inc. · DRX Electrode, Electrocardiograph
Cleared on Aug 18, 2000 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled once.
- Decided
- Aug 18, 2000
- Review
- 25 days
- Class
- Class II
- Product code
- DRX
- Recalls
- 1
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK002230 Cambridge Heart Micro-V Alternans Sensor, Model 20327-002Cambridge Heart, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK013615 Micro-Induction 1000 SystemHarbinger Medical, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK090249 Modification to: Micro-Induction 1000 SystemHarbinger Medical, Inc. · 2009
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 |
|---|---|---|---|---|---|
| 0 (this device) | K002230 | Cambridge Heart Micro-V Alternans Sensor, Model 20327-002 | Cambridge Heart, Inc. | 2000 | — |
| +1 | K013615 | Micro-Induction 1000 System | Harbinger Medical, Inc. | 2002 | — |
| +2 | K090249 | Modification to: Micro-Induction 1000 System | Harbinger Medical, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2009 | 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 DRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013615 | Micro-Induction 1000 System | 2002 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 29, 2010 | Not classified | Z-1776-2010 | Process control | Some kits contained a component with expiration date prior to the date of expiry on the outside of the kit. The user receives feedback of potential unreliable results at several stages during the test process, so any risk of unreliable… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K013615 (Harbinger Medical, Inc., 2002) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DRX devicesDRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRX
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DRX
78in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRX
6in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRX
250in 2025
MAUDE reports naming product code DRX, 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 | 3 | 147 | 0 | 47 |
| 2008 | 3 | 17 | 0 | 15 |
| 2009 | 7 | 89 | 0 | 36 |
| 2010 | 5 | 78 | 4 | 48 |
| 2011 | 0 | — | 0 | 80 |
| 2012 | 0 | — | 0 | 41 |
| 2013 | 1 | — | 0 | 70 |
| 2014 | 1 | — | 0 | 27 |
| 2015 | 0 | — | 1 | 58 |
| 2016 | 0 | — | 0 | 37 |
| 2017 | 1 | — | 0 | 55 |
| 2018 | 0 | — | 0 | 43 |
| 2019 | 0 | — | 0 | 50 |
| 2020 | 0 | — | 5 | 53 |
| 2021 | 0 | — | 1 | 55 |
| 2022 | 0 | — | 6 | 61 |
| 2023 | 0 | — | 0 | 113 |
| 2024 | 0 | — | 0 | 61 |
| 2025 | 0 | — | 0 | 250 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K002230 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002230: Cambridge Heart Micro-V Alternans Sensor, Model 20327-002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002230
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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