510(k) · Cleared
ClearedPhase 3, Model DT-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datrend Systems, Inc. · DRL Tester, Defibrillator
Cleared on Jan 25, 2007 as substantially equivalent to K941404 (Hogan & Hartson, 1994) after a 185-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jan 25, 2007
- Review
- 185 days
- Class
- Class II
- Product code
- DRL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941404 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK941404 Impulse 4000 Defibrillator/Transcutaneous Pacer AnalyzerHogan & Hartson · 1994
- This deviceK062099 Phase 3, Model DT-1Datrend Systems, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941404 | Impulse 4000 Defibrillator/Transcutaneous Pacer Analyzer | Hogan & Hartson | 1994 | — |
| 0 (this device) | K062099 | Phase 3, Model DT-1 | Datrend Systems, Inc. | 2007 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K941404 | Impulse 4000 Defibrillator/Transcutaneous Pacer Analyzer | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K941404.
How does its category compare?
All DRL devicesDRL Tester, Defibrillator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DRL
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · DRL
Too few DRL 510(k)s in any year since 2007 to give a median.
Recalls per year · DRL
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRL
2in 2013
MAUDE reports naming product code DRL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (255 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062099 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062099: Phase 3, Model DT-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062099
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026