# K152135: Quantitative Electrocardiographic Detector (QED 2000)

- Pathway: 510(k) (Traditional)
- Applicant: Acme Portable Machines, Inc.
- Decided: Aug 9, 2016 after 375 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K921669 (1993). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113144: Pagewriter TC 20, 30, 50, 70, Philips Medical Systems (2012) Summary page 4.
- K110266: Mac 5500 HD, Mac 3500, Ge Medical Systems Information Technologies, Inc. (2011) Summary page 4.

## Indications for use
The intended use of the QED2000 is to record 12-lead ECG signals from patient’s heart activity through body surface ECG electrodes. This device can acquire, display, record, analyze, and store these ECG signals from adult patients for review by the user. Analysis of the ECG signals is accomplished with algorithms that provide data presentations, graphical presentations, and measurements. These are presented for review and interpretation by a trained physician or clinician in determining a diagnosis based upon knowledge of the patient, the result of physical examination, and other clinical findings. The QED2000 is intended to be used in hospital and general physician’s office by trained healthcare professionals.

Source page: https://510kreport.com/device/K152135
Methodology: https://510kreport.com/methodology