# K001305: Mac-Lab System and Cardiolab EP System

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Jun 27, 2000 after 64 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 1 cites it directly.
0 of 32 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
- K021366: Mac-Lab/Cardiolab EP/Combolab (2002), 30 descendants of its own
- K032577: Modification to: Mac-Lab/Cardiolab EP/Combolab System (2003), 29 descendants of its own
- K050093: Mac-Lab/Cardiolab EP/Combolab System (2005), 15 descendants of its own
- K113811: V2.6 Software for the Labsystem Pro EP Recording System (2012), 12 descendants of its own
- K061741: Mac-Lab/Cardiolab /Combolab/Specialslab System (2006), 10 descendants of its own

Source page: https://510kreport.com/device/K001305
Methodology: https://510kreport.com/methodology