510(k) · Cleared
Recalled · 2010Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical, Model 3085 Dual-Chamber External Pulse Gene
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osypka Medical, Inc. · DTE Pulse-Generator, Pacemaker, External
Cleared on Jun 14, 2002 as substantially equivalent to K910237 (Medtronic Vascular, 1991) and 3 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 14, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- DTE
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 1 generation to K893633 (1989). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK893633 Model 5330 External a-V Sequential Demand PulseMedtronic Vascular · 1989
- This deviceK020896 Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude…Osypka Medical, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK022939 Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and…Osypka Medical, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK033130 Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse GeneratorOsypka Medical, Inc. · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K893633 | Model 5330 External a-V Sequential Demand Pulse | Medtronic Vascular | 1989 | — |
| 0 (this device) | K020896 | Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical… | Osypka Medical, Inc. | 2002 | — |
| +1 | K022939 | Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and… | Osypka Medical, Inc. | 2002 | — |
| +1 | K033130 | Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse Generator | Osypka Medical, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 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 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? (4)
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 |
|---|---|---|---|
| * | K910237 | Modified Model 5330 AV Demand Pulse GeneratorSummary page 1…Classification 870.3600 Pulse-Generator, Pacemaker, External Names: 870.2900 Cables, Transducer and Electrode Predicate K910237 MEDTRONIC" MODIFIED MODEL 5330 Devices: A-V Demand Pulse Generator… | 1991 |
| * | K893633 | Model 5330 External a-V Sequential Demand PulseSummary page 1…rode Predicate K910237 MEDTRONIC" MODIFIED MODEL 5330 Devices: A-V Demand Pulse Generator K893633 MEDTRONICTMODEL 5330 External A-V Sequential Demand Pulse Generator… | 1989 |
| * | K970497 | PACE 101HSummary page 1…K893633 MEDTRONICTMODEL 5330 External A-V Sequential Demand Pulse Generator K970497 OSCOR" D-1 / D-13 / 0-5 / D-9 / D-10 Extension Cables PACE 101H Arm Strap… | 1997 |
| * | K923621 | External Demand PacemakerSummary page 1…K970497 OSCOR" D-1 / D-13 / 0-5 / D-9 / D-10 Extension Cables PACE 101H Arm Strap K923621 OSCOR" DX-2 / 0-5 / D-I 0 Extension Cables PACE 100H Arm Strap Devic… | 1993 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 30, 2010 | Not classified | Z-2443-2010 | Device Design | The recall was initiated after Osypka Medical received two (2) complaints from their Japanese distributor regarding an incompatibility of the PACE 203H with some new types of 9 V batteries. The investigation revealed that PACE 203H of a… |
| Jun 30, 2010 | Not classified | Z-2444-2010 | Device Design | The recall was initiated after Osypka Medical received two (2) complaints from their Japanese distributor regarding an incompatibility of the PACE 203H with some new types of 9 V batteries. The investigation revealed that PACE 203H of a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 4 ancestors has a recall.
- Of its descendants, K022939 (Osypka Medical, Inc., 2002) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The PACE 203 / PACE 203H / MODEL 3085 external pulse generator / temporary pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular or A-V sequential pacing. The PACE 203 / PACE 203H / MODEL 3085 has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes. Specific indications include, but are not limited to, the following: Sick Sinus Syndrome; Bradycardia with…
Read the full statement (187 words)
The PACE 203 / PACE 203H / MODEL 3085 external pulse generator / temporary pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular or A-V sequential pacing. The PACE 203 / PACE 203H / MODEL 3085 has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes.
Specific indications include, but are not limited to, the following:
Sick Sinus Syndrome;
Bradycardia with congestive heart failure;
Complete heart block;
Acute myocardial infarction complicated by heart block;
Sinus bradycardia;
Cardiac arrest with ventricular asystole;
Atrial and/or ventricular ectopic arrhythmia;
Postoperatively after cardiac surgery;
Temporary application during implantation or exchange of permanent pacemaker.
Indication for atrial overdrive stimulation (rapid atrial pacing):
Supra-ventricular tachycardia.
The PACE 203 / PACE 203H / MODEL 3085 can be used to measure atrial or ventricular voltage stimulation thresholds and determine the approximate P wave potentials sensed via the atrial pacing lead electrodes and the approximate R wave potentials sensed via the ventricular pacing lead electrodes.
The XI.TME and XI.RAC Extension Cables are used with external pulse generators / temporary cardiac pacemakers and pacing system analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020896 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020896: Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical, Model 3085 Dual-Chamber External Pulse Gene.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020896
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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