# K062099: Phase 3, Model DT-1

- Pathway: 510(k) (Traditional)
- Applicant: Datrend Systems, Inc.
- Decided: Jan 25, 2007 after 185 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 K941404 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941404: Impulse 4000 Defibrillator/Transcutaneous Pacer Analyzer, Hogan & Hartson (1994)

## Indications for use
Datrend Systems Inc. Phase 3 Defibrillator/PacerAnalyzeris a precision instrument for ensuring that defibrillators and defibrillators with transcutaneous pacemakers comply with performance specifications. Phase 3 is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load. It can also provide waveform information. Phase 3's main function is to measure the energy output of a defibrillator. The instrument has a built-in load resistance of 50 ohms, which roughly corresponds to the impedance of the human body. The defibrillator paddles are connected to Phase 3 contact plates, or directly connected to the energy input if using the hands-free defibrillator function. Thus, the defibrillator is connected through the load resistance of Phase 3. When the defibrillator is discharged, Phase 3 will calculate and display the energy delivered. The intended end user is a trained / skilled biomedical equipment technician who is required to perform incoming inspections, scheduled periodic maintenance, and repair servicing of defibrillators, both stand alone and with pacing. Such end users may be associated with public, private, or commercial institutions, including: hospitals, clinics, third-party service companies that repair or calibrate medical equipment. In general, the end user is a technically trained individual, at a post-secondary school level, specializing in medical instrumentation technology. Phase 3 is intended to be used in the laboratory environment, outside of the patient care vicinity, and is not intended to be used on patients or to test devices while connected to patients. Phase 3 is not intended for over-the-counter use.

Source page: https://510kreport.com/device/K062099
Methodology: https://510kreport.com/methodology