510(k) · Cleared
ClearedModel 220 Patient Magnet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cyberonics, Inc. · DTG Magnet, Test, Pacemaker
Cleared on Nov 3, 2009 as substantially equivalent to K813153 (Pacesetter Systems, 1981) after a 90-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Nov 3, 2009
- Review
- 90 days
- Class
- Class I
- Product code
- DTG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K813153 (1981). No later device cites it as a predicate yet.
- Root · 1 generation backK813153 Test MagnetPacesetter Systems · 1981
- This deviceK092364 Model 220 Patient MagnetCyberonics, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K813153 | Test Magnet | Pacesetter Systems | 1981 | — |
| 0 (this device) | K092364 | Model 220 Patient Magnet | Cyberonics, Inc. | 2009 | — |
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 |
|---|---|---|---|
| * | K813153 | Test MagnetSummary page 1…erator's surface and oriented with the magnet's axis parallel to the longitudinal axis of the reed switch. Predicate Devices: Pacesetter Systems, Pacemaker Test Magnet (K813153) Substantial Equivalence: The Model 220 Patient Magnet is similar with respect to intended use and materials to the above 510(k)… | 1981 |
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 DTG devicesDTG Magnet, Test, Pacemaker: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 patient magnet is used to close the reed switch of a pulse generator when held above the reed switch, 1 inch from the generator's surface, and oriented with the magnet's axis parallel to the longitudinal axis of the reed switch.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092364: Model 220 Patient Magnet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092364
Report an extraction error
Are you the manufacturer?
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