510(k) · Cleared
ClearedModification to Zap Guard Defibrillator Test Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guardian Angel Products, Inc. · DRL Tester, Defibrillator
Cleared on Jul 11, 2003 as substantially equivalent to K896985 (Guardian Angel Products, Inc., 1990) after a 141-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Jul 11, 2003
- Review
- 141 days
- Class
- Class II
- Product code
- DRL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K896985 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK896985 Zap-GuardGuardian Angel Products, Inc. · 1990
- This deviceK030547 Modification to Zap Guard Defibrillator Test ProbeGuardian Angel Products, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896985 | Zap-Guard | Guardian Angel Products, Inc. | 1990 | — |
| 0 (this device) | K030547 | Modification to Zap Guard Defibrillator Test Probe | Guardian Angel Products, Inc. | 2003 | — |
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 |
|---|---|---|---|
| * | K896985 | Zap-GuardSummary page 1…ont Ave Huntingdon Valley, PA 19006 Common or Usual Name: Defibrillator Testing Probe Classification Name: Tester, Defibrillator Predicate Devices: Z A P GUARD (K896985) Purpose of 510(k): The purpose of this Special 510(k) is t o m o w y the Z A P GUARD device used for testing monop… | 1990 |
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.
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 | — |
What is it indicated for?
The ZAP GUARD II is intended to be used for testing the continuity and integrity of the wires of Biphasic Defibrillator Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030547: Modification to Zap Guard Defibrillator Test Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030547
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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