510(k) Report

510(k) · Cleared

Cleared

Sigma Pace External Pacemaker Analyzer Model #1000

K011729510(k) TraditionalCleared Aug 30, 200187-day reviewClass II21 CFR 870.3630

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

Dni Nevada, Inc. · DTC Analyzer, Pacemaker Generator Function

Cleared on Aug 30, 2001 as substantially equivalent to K961582 (North American Technical Services Corp., 1996) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1991.

Decided
Aug 30, 2001
Review
87 days
Class
Class II
Product code
DTC
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K903966 (1991). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestorK903966 · External Pacemaker Analyzer Model Pma-1 · Bio-Tek Instruments, Inc. · 19911990199219941996199820002002
Other ancestors, by generation 1 generation back: 1 other ancestor K903966 · External Pacemaker Analyzer Model Pma-1 · Bio-Tek Instruments, Inc. · 19910
  1. Root · 1 generation backK903966 External Pacemaker Analyzer Model Pma-1Bio-Tek Instruments, Inc. · 1991
  2. This deviceK011729 Sigma Pace External Pacemaker Analyzer Model #1000Dni Nevada, Inc. · 2001
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K903966External Pacemaker Analyzer Model Pma-1Bio-Tek Instruments, Inc.1991—
0 (this device)K011729Sigma Pace External Pacemaker Analyzer Model #1000Dni Nevada, Inc.2001—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K011729, 1991–2001Source: 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 DTC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (2)

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
*K961582External Pacemaker Analyzer, Model PMT 100
Summary page 1
…y Equivalent To: The device is substantially equivalent to the following two legally marketed predicate devices: - Netech, Model EXPMT 100 External Pacemaker Tester, #K961582 \ - Bio-Tek Inc, Model PMA-1 Pacemaker Analyzer, #K903966 SigmaPace 1000 and the predicate External Pacemaker Analyzers have the…
North American Technical Services Corp.1996—
*K903966External Pacemaker Analyzer Model Pma-1
Summary page 1
…o the following two legally marketed predicate devices: - Netech, Model EXPMT 100 External Pacemaker Tester, #K961582 \ - Bio-Tek Inc, Model PMA-1 Pacemaker Analyzer, #K903966 SigmaPace 1000 and the predicate External Pacemaker Analyzers have the identical intended use and there are no new technological…
Bio-Tek Instruments, Inc.1991—

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?

  • None of the 2 ancestors has a recall.

How does its category compare?

All DTC devices

DTC Analyzer, Pacemaker Generator Function: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTC

1in 2017

2009: 12017: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTC

Too few DTC 510(k)s in any year since 2007 to give a median.

Recalls per year · DTC

No recall names DTC since 2007.

Adverse event reports per year · DTC

1,159in 2025

2010: 22011: 12014: 12017: 342018: 222019: 1382020: 1892021: 6362022: 2182023: 2152024: 1,0762025: 1,159
2007high 1,159 (2025) · low 0 (2007)2025

MAUDE reports naming product code DTC, 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—00
20080—00
20091—00
20100—02
20110—01
20120—00
20130—00
20140—01
20150—00
20160—00
20171—034
20180—022
20190—0138
20200—0189
20210—0636
20220—0218
20230—0215
20240—01,076
20250—01,159
20260—0—

What is it indicated for?

The SigmaPace 1000 External Pacemaker Analyzer is intended for use as regular preventative maintenance and quality assurance checks on external cardiac pacemakers utilized in both the pre-hospital and hospital based environments. The SigmaPace 1000 is limited to preventative maintenance checks for transcutaneous and transvenous types of temporary external cardiac pacemakers. The SigmaPace 1000 will perform a full range of device-specific testing…

Read the full statement (191 words)

The SigmaPace 1000 External Pacemaker Analyzer is intended for use as regular preventative maintenance and quality assurance checks on external cardiac pacemakers utilized in both the pre-hospital and hospital based environments.

The SigmaPace 1000 is limited to preventative maintenance checks for transcutaneous and transvenous types of temporary external cardiac pacemakers. The SigmaPace 1000 will perform a full range of device-specific testing procedures and protocols developed by the external cardiac pacemaker manufacturers. The SigmaPace 1000 will also provide interactive pacemaker simulation capabilities for applications in clinical training and product demonstration.

The SigmaPace 1000 is intended to be used by biomedical technicians, OEM manufacturers, and third party service facilities to perform preventative maintenance and quality assurance checks on external cardiac pacemakers, to verify the operation of devices returned from repair, and to assist repair facilities in the diagnosis of intermittent operations. The device may also be used by training facilities to train medical personnel.

The SigmaPace 1000 is not used on patients and does not perform any diagnostic, therapeutic, or monitoring functions. Additionally, these devices are not used to test any programmable, implantable pacemakers or any related indwelling cardiovascular catheters or lead wires.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Recent decisions in DTC

The DTC category page

  • K170815PSA CableBoston Scientific Corporation · 2017
  • K083674PK-141 Patient CableBiotronik, Inc. · 2009
  • K002497Model 4810 Analyzer Output AdapterPace Medical · 2000
  • K961582External Pacemaker Analyzer, Model PMT 100North American Technical Services Corp. · 1996
  • K903966External Pacemaker Analyzer Model Pma-1Bio-Tek Instruments, Inc. · 1991

https://510kreport.com/device/K011729 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011729: Sigma Pace External Pacemaker Analyzer Model #1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011729

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 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026