# K002230: Cambridge Heart Micro-V Alternans Sensor, Model 20327-002

- Pathway: 510(k) (Special)
- Applicant: Cambridge Heart, Inc.
- Decided: Aug 18, 2000 after 25 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013615: Micro-Induction 1000 System (2002), 1 descendant of its own
- K090249: Modification to: Micro-Induction 1000 System (2009), 0 descendants of its own

## Recalls of this device
- Apr 29, 2010 · Not classified · Z-1776-2010: 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

Source page: https://510kreport.com/device/K002230
Methodology: https://510kreport.com/methodology