510(k) · Cleared
ClearedImpulse 4000 Defibrillator/Transcutaneous Pacer Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hogan & Hartson · DRL Tester, Defibrillator
Cleared on Jun 29, 1994 after a 98-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Jun 29, 1994
- Review
- 98 days
- Class
- Class II
- Product code
- DRL
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK941404 Impulse 4000 Defibrillator/Transcutaneous Pacer AnalyzerHogan & Hartson · 1994
- Descendant · cites it directly · 0 of its ownK062099 Phase 3, Model DT-1Datrend Systems, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK954391 Models Qed-6, 6M and 6H Defibrillator Analyzer with Optional…Bio-Tek Instruments, Inc. · 1995
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941404 | Impulse 4000 Defibrillator/Transcutaneous Pacer Analyzer | Hogan & Hartson | 1994 | — |
| +1 | K062099 | Phase 3, Model DT-1 | Datrend Systems, Inc. | 2007 | — |
| +1 | K954391 | Models Qed-6, 6M and 6H Defibrillator Analyzer with Optional Universal… | Bio-Tek Instruments, Inc. | 1995 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K062099 (Datrend Systems, Inc., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DRL devicesDRL Tester, Defibrillator: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K941404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941404: Impulse 4000 Defibrillator/Transcutaneous Pacer Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941404
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026