510(k) · Cleared
ClearedModified Model 5330 AV Demand Pulse Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DTE Pulse-Generator, Pacemaker, External
Cleared on Feb 25, 1991 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Feb 25, 1991
- Review
- 38 days
- Class
- Class II
- Product code
- DTE
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK910237 Modified Model 5330 AV Demand Pulse GeneratorMedtronic Vascular · 1991
- Descendant · cites it directly · 2 of its ownK020896 Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude…Osypka Medical, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 1 of its ownK022939 Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and…Osypka Medical, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK033130 Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse GeneratorOsypka Medical, Inc. · 2003
Most influential descendants
Showing 3 of 3 · See all- K020896Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical, Model 3085…Osypka Medical, Inc. · 2002 · cites it directly2descendants
- K022939Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and…Osypka Medical, Inc. · 2002 · 2 generations on1descendant
- K033130Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse GeneratorOsypka Medical, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910237 | Modified Model 5330 AV Demand Pulse Generator | Medtronic Vascular | 1991 | — |
| +1 | K020896 | Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical… | Osypka Medical, Inc. | 2002 | 2 |
| +2 | K022939 | Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and… | Osypka Medical, Inc. | 2002 | — |
| +2 | K033130 | Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse Generator | Osypka Medical, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 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 DTE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DTE device
- #1 K232721 Lifetech Cardio Temporary Pacemakerscore 7.2 · 3 generations · no Class I recall
- #2 Held for the reportin 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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020896 | Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical, Model 3085… | 2002 | 2 |
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, K020896 (Osypka Medical, Inc., 2002) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DTE devicesDTE Pulse-Generator, Pacemaker, External: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTE
Too few DTE 510(k)s in any year since 2007 to give a median.
Recalls per year · DTE
2in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTE
636in 2025
MAUDE reports naming product code DTE, 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 | 17 |
| 2008 | 0 | — | 0 | 22 |
| 2009 | 0 | — | 0 | 39 |
| 2010 | 0 | — | 2 | 335 |
| 2011 | 0 | — | 0 | 1,865 |
| 2012 | 0 | — | 0 | 1,786 |
| 2013 | 2 | — | 0 | 98 |
| 2014 | 0 | — | 0 | 67 |
| 2015 | 1 | — | 0 | 342 |
| 2016 | 2 | — | 0 | 496 |
| 2017 | 0 | — | 0 | 654 |
| 2018 | 2 | — | 0 | 956 |
| 2019 | 2 | — | 0 | 1,001 |
| 2020 | 1 | — | 0 | 1,092 |
| 2021 | 0 | — | 0 | 899 |
| 2022 | 0 | — | 0 | 833 |
| 2023 | 0 | — | 0 | 650 |
| 2024 | 1 | — | 0 | 620 |
| 2025 | 1 | — | 0 | 636 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K910237 · printed Nov 3, 2026
Cite this page
510(k) Report. “K910237: Modified Model 5330 AV Demand Pulse Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K910237
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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