# K011000: Tram 2001 Module

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Jun 29, 2001 after 87 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- 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.
54 later devices descend from it; 2 cite it directly.
1 of 55 devices in its family (counting itself) has 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
- K042642: Aware Transport Monitor System (Includes Aware Pod and Aware Transport Monitor) (2004), 52 descendants of its own
- K071073: Solar 8000 and Transport Pro with Patient Data Module (2007), 51 descendants of its own
- K092027: Carescape Monitor B850 (2009), 38 descendants of its own
- K102239: Carescape Monitor B650 (2010), 32 descendants of its own
- K132533: Carescape Monitor B450 (2013), 14 descendants of its own

## Recalls of this device
- Dec 5, 2013 · Class II · Z-0808-2014: Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. May result in reduced ECG, Respiration and arrhythmia d

Source page: https://510kreport.com/device/K011000
Methodology: https://510kreport.com/methodology