510(k) Report

510(k) · Cleared

Cleared

External Demand Pacemaker

K923621510(k) TraditionalCleared May 19, 1993302-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

Oscor Medical Corp. · DTE Pulse-Generator, Pacemaker, External

Cleared on May 19, 1993 after a 302-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
May 19, 1993
Review
302 days
Class
Class II
Product code
DTE
Recalls
None
Predicates
0

3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared2003: 1 descendant cleared1990200020102020
  1. This deviceK923621 External Demand PacemakerOscor Medical Corp. · 1993
  2. Descendant · cites it directly · 2 of its ownK020896 Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude…Osypka Medical, Inc. · 2002 · Recalled
  3. Descendant · cites it directly · 1 of its ownK022939 Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and…Osypka Medical, Inc. · 2002
  4. 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 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 · cites it directly1descendant
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K923621External Demand PacemakerOscor Medical Corp.1993—
+1K020896Oscor 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—
+1K033130Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse GeneratorOsypka Medical, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200310
FIG. 1 — Lineage of K923621, 1993–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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. #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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K020896Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical, Model 3085…Osypka Medical, Inc.20022
K022939Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and…Osypka Medical, Inc.20021
K033130Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse GeneratorOsypka Medical, Inc.20030

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 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—

More from Oscor Medical Corp.

31 FDA decisions under this applicant name. See the company

  • K964107Oscor Permanent Retractable Screw-in Pacing Lead Model PROscor Medical Corp. · 1997
  • K925168Miscellaneous Pacing LeadOscor Medical Corp. · 1994
  • K912867Oscor Medical Corp Permanent Pacing LeadOscor Medical Corp. · 1992
  • K915008Permanent Pacing Pad, ModificationOscor Medical Corp. · 1992
  • K915007Permanent Pacing Leads, ModificationOscor Medical Corp. · 1992

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/K923621 · printed Nov 6, 2026

Cite this page

510(k) Report. “K923621: External Demand Pacemaker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923621

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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