# K954391: Models Qed-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Tek Instruments, Inc.
- Decided: Nov 17, 1995 after 59 days
- Product code: DRL (Tester, Defibrillator)
- Device class: 2
- Regulation: 21 CFR 870.5325
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904159 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904159: Defibrillator Analyzer Model Qed-5, Bio-Tek Instruments, Inc. (1991) Summary page 1.
- K903966: External Pacemaker Analyzer Model Pma-1, Bio-Tek Instruments, Inc. (1991). Our reading of the summary gave K903166, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Bio-Tek PMA-1 Pacemaker Analyzer”.
- K941404: Impulse 4000 Defibrillator/Transcutaneous Pacer Analyzer, Hogan & Hartson (1994) Summary page 1.

## Indications for use
The QED-6 comprises a series of defibrillator analyzers with pacemaker analysis features. The devices have identical hardware, which can be factory modified by software to configure various options. The devices are intended to be used to: A) Analyze the energy which is delivered by defibrillator, including Joules, peak current, peak voltage and overshoot. Output to a printer or oscilloscope in order to “playback” the defibrillator pulse waveform and output the other information which the analyzer has recorded. These features are on all models, QED-6, QED-6M, and QED-6H. B) Measure synchronization time (cardiovascular delay time) of synchronized defibrillators. All models QED-6, QED-6M and QED-6H. C) Output a variety of performance and arrhythmia waveforms to the defibrillator paddles or ECG jacks for monitor verification. Models QED-6M and QED-6H. D) Measure charge time of defibrillator. Models QED-6M and QED-6H. E) Analyze the output signals of non-invasive pacemakers, such as the transthoracic types which are present on some defibrillators, such as the Physio Controls LifePak 8. On Model QED-6H.

Source page: https://510kreport.com/device/K954391
Methodology: https://510kreport.com/methodology