510(k) · Cleared
ClearedMagno Alarm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiac Assist Devices, Inc. · DTG Magnet, Test, Pacemaker
Cleared on Mar 26, 1997 after a 400-day review. The FDA summary names its predicate without a number.
- Decided
- Mar 26, 1997
- Review
- 400 days
- Class
- Class I
- Product code
- DTG
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 DTG? 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 |
|---|---|---|---|
| * | — | test magnets employed as an external and non-contacting auxiliary tool for… Named without a submission number |
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.
How does its category compare?
All DTG devicesDTG Magnet, Test, Pacemaker: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTG
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · DTG
Too few DTG 510(k)s in any year since 2007 to give a median.
Recalls per year · DTG
No recall names DTG since 2007.
Adverse event reports per year · DTG
3in 2024
MAUDE reports naming product code DTG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Magno Alarm is a device that in presence of magnetic fields produce sound and light signals to be noticed by the hearing and sight senses of an individual who is using it.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960849 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960849: Magno Alarm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960849
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026