510(k) · Cleared

Cleared

Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and Accessories,Cardiotronic Pace 101 and Accessories

K022939510(k) SpecialCleared Oct 3, 200229-day reviewClass II21 CFR 870.3600

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Osypka Medical, Inc. · DTE Pulse-Generator, Pacemaker, External

Cleared on Oct 3, 2002 as substantially equivalent to K970497 (Sulzer Oscor, Inc., 1997) and 2 other predicates after a 29-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.

Decided: Oct 3, 2002
Review: 29 days
Class: Class II
Product code: DTE
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K893633 (1989). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK893633 Model 5330 External a-V Sequential Demand PulseMedtronic Vascular · 1989
1 generation backK020896 Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude…Osypka Medical, Inc. · 2002 · Recalled
This deviceK022939 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 1 of 1 · See all

K033130Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse GeneratorOsypka Medical, Inc. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K893633	Model 5330 External a-V Sequential Demand Pulse	Medtronic Vascular	1989	—
−1	K020896	Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical…	Osypka Medical, Inc.	2002	2
0 (this device)	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
2003	1	0

FIG. 1 — Lineage of K022939, 1989–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	K970497	PACE 101H Summary page 1 …ssification 870,3600 Pulse-Generator, Pacemaker, External Names: 870.2900 Cables, Transducer and Electrode Predicate K970497 OSCOR@PACE 101H External Pacemaker Devices: Kg23621 OSCOR@PACE 100H Externa…	Sulzer Oscor, Inc.	1997	—
*	K923621	External Demand Pacemaker Summary page 1 …K970497 OSCOR@D-I / D-3 / D-5 / D-9 / D-10 Extension Cables PACE 101H Arm'Strap K923621 OSCOR@DX-2 / D-5 / D-10 Extension Cables PACE 100H Arm Strap Devi…	Oscor Medical Corp.	1993	—
*	K020896	Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical, Model 3085…	Osypka Medical, Inc.	2002	2

Also cleared against K970497: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K033130	Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse Generator	Osypka Medical, Inc.	2003	0

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?

The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 13.0 years on median.
1 of the 5 ancestors has a recall of any class.
Of its descendants, K033130 (Osypka Medical, Inc., 2003) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K970497.

How does its category compare?

All DTE devices

DTE Pulse-Generator, Pacemaker, External: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTE

1in 2025

2007high 2 (2013) · low 0 (2007)2026

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

2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DTE

636in 2025

2007high 1,865 (2011) · low 17 (2007)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 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular pacing. When combined with a stimulation lead system, the PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator can be used whenever temporary atrial or ventricular pacing is indicated. The device can be employed for therapeutic as well as diagnostic purposes or may be used…

Read the full statement (143 words)

The PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular pacing.

When combined with a stimulation lead system, the PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator can be used whenever temporary atrial or ventricular pacing is indicated. The device can be employed for therapeutic as well as diagnostic purposes or may be used prophylactically.

Specific indications for temporary pacing include, but are not limited to:

Complete (third-degree) or intermittent heart block;

Symptomatic sinus bradycardia;

Atrial and/or ventricular ectopic arrhythmia;

Sick Sinus Syndrome (SSS);

Atrial tachyarrhythmia;

Acute myocardial infarction-induced heart block;

Stimulation during ventricular asystole;

Use during the replacement of an implantable pulse generator;

Stimulation and monitoring before the implantation of a cardiac pulse generator;

Stimulation and monitoring following heart surgery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022939 · printed Nov 5, 2026

Cite this page

510(k) Report. “K022939: Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and Accessories,Cardiotronic Pace 101 and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022939

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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