510(k) · Cleared
ClearedImpulse 7010 Defibrillator Selectable Loads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fluke Biomedical · DRL Tester, Defibrillator
Cleared on Dec 24, 2008 after a 41-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Dec 24, 2008
- Review
- 41 days
- Class
- Class II
- Product code
- DRL
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK083347 Impulse 7010 Defibrillator Selectable LoadsFluke Biomedical · 2008
- Descendant · cites it directly · 0 of its ownK153210 Defibrillator Analyzer Variable LoadBc Group International, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K153210Defibrillator Analyzer Variable LoadBc Group International, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083347 | Impulse 7010 Defibrillator Selectable Loads | Fluke Biomedical | 2008 | — |
| +1 | K153210 | Defibrillator Analyzer Variable Load | Bc Group International, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
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 |
|---|---|---|---|
| * | — | Phase 3 Variable Load Module (VLM) Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153210 | Defibrillator Analyzer Variable Load | 2015 | 0 |
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, K153210 (Bc Group International, Inc., 2015) 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. 2008, 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?
The impulse 7010 is used to determine that a defibrillator is performing within its operating
specifications by providing multiple loads of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms.
The Impulse 7010 is used in conjunction with the Impulse 7000DP Defibrillator Analyzer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083347 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083347: Impulse 7010 Defibrillator Selectable Loads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083347
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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