510(k) Report

510(k) · Cleared

Cleared

Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse Generator

K033130510(k) SpecialCleared Oct 31, 200331-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 31, 2003 as substantially equivalent to K022939 (Osypka Medical, Inc., 2002) and 3 other predicates after a 31-day review. Its family tree reaches back 3 generations to 1989.

Decided
Oct 31, 2003
Review
31 days
Class
Class II
Product code
DTE
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K893633 (1989). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1993: 1 other ancestor1991: 1 other ancestorK893633 · Model 5330 External a-V Sequential Demand Pulse · Medtronic Vascular · 1989K020896 · Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical, Model 3085 Dual-Chamber External Pulse Gene · Osypka Medical, Inc. · 2002 · recalledK022939 · Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and Accessories,Cardiotronic Pace 101 and Accessories · Osypka Medical, Inc. · 200219851990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor K022939 · Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and Accessories,Cardiotronic Pace 101 and Accessories · Osypka Medical, Inc. · 2002K020896 · Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical, Model 3085 Dual-Chamber External Pulse Gene · Osypka Medical, Inc. · 2002 · recalledK893633 · Model 5330 External a-V Sequential Demand Pulse · Medtronic Vascular · 19890
  1. Root · 3 generations backK893633 Model 5330 External a-V Sequential Demand PulseMedtronic Vascular · 1989
  2. 2 generations backK020896 Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude…Osypka Medical, Inc. · 2002 · Recalled
  3. 1 generation backK022939 Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and…Osypka Medical, Inc. · 2002
  4. This deviceK033130 Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse GeneratorOsypka Medical, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K893633Model 5330 External a-V Sequential Demand PulseMedtronic Vascular1989—
−2K020896Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical…Osypka Medical, Inc.20022
−1K022939Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and…Osypka Medical, Inc.2002—
0 (this device)K033130Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse GeneratorOsypka Medical, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199310
199710
FIG. 1 — Lineage of K033130, 1989–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K232721 Lifetech Cardio Temporary Pacemakerscore 7.2 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K022939Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and…Osypka Medical, Inc.2002—
*K970497PACE 101H
Summary page 1
…al Pacemaker Devices: ST. JUDE MEDICAL" Model 3077 CARDIOTRONIC" PACE 101" K970497 OSCOR@PACE 101H External Pacemaker K923621 OSCOR@PACE 1OOH External Pacemaker…
Sulzer Oscor, Inc.1997—
*K923621External Demand Pacemaker
Summary page 1
…l 3077 CARDIOTRONIC" PACE 101" K970497 OSCOR@PACE 101H External Pacemaker K923621 OSCOR@PACE 1OOH External Pacemaker KO20896 XLTME" and XI.RAC" Extension Cables…
Oscor Medical Corp.1993—
*K020896Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical, Model 3085…Osypka Medical, Inc.20022

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?

  • The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
  • 1 of the 6 ancestors has a recall of any class.

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

2013: 22015: 12016: 22018: 22019: 22020: 12024: 12025: 1
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

2010: 2
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

2007: 172008: 222009: 392010: 3352011: 1,8652012: 1,7862013: 982014: 672015: 3422016: 4962017: 6542018: 9562019: 1,0012020: 1,0922021: 8992022: 8332023: 6502024: 6202025: 636
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—017
20080—022
20090—039
20100—2335
20110—01,865
20120—01,786
20132—098
20140—067
20151—0342
20162—0496
20170—0654
20182—0956
20192—01,001
20201—01,092
20210—0899
20220—0833
20230—0650
20241—0620
20251—0636
20260—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 duiing 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.

More from Osypka Medical, Inc.

7 FDA decisions under this applicant name. See the company

  • K123916Psa SeriesOsypka Medical, Inc. · 2013
  • K082242Icon, Model C3Osypka Medical, Inc. · 2008
  • K081035Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2 and Aesculon Pacemaker Clinic C2Osypka Medical, Inc. · 2008
  • K070985Aesculon CHF, Hypertension & Pacemaker ClinicOsypka Medical, Inc. · 2008
  • K022939Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and Accessories,Cardiotronic Pace 101 and…Osypka Medical, Inc. · 2002

Recent decisions in DTE

The DTE category page

  • K241781Solo Pace ControlSolo Pace, Inc. · 2025
  • K232721Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd. · 2024
  • K201011Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2020
  • K190825Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2019
  • K182839Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd. · 2019

https://510kreport.com/device/K033130 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033130: Pace 101/Pace 101H, Model 3077 Ssi Temporary 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/K033130

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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