510(k) Report

510(k) · Cleared

Cleared

External Pacemaker Analyzer Model Pma-1

K903966510(k) TraditionalCleared Jun 19, 1991295-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

Bio-Tek Instruments, Inc. · DTC Analyzer, Pacemaker Generator Function

Cleared on Jun 19, 1991 after a 295-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Jun 19, 1991
Review
295 days
Class
Class II
Product code
DTC
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1995: 1 descendant cleared2001: 1 descendant cleared1990200020102020
  1. This deviceK903966 External Pacemaker Analyzer Model Pma-1Bio-Tek Instruments, Inc. · 1991
  2. Descendant · cites it directly · 0 of its ownK011729 Sigma Pace External Pacemaker Analyzer Model #1000Dni Nevada, Inc. · 2001
  3. Descendant · cites it directly · 0 of its ownK954391 Models Qed-6, 6M and 6H Defibrillator Analyzer with Optional…Bio-Tek Instruments, Inc. · 1995

Most influential descendants

Showing 2 of 2 · See all
  • K011729Sigma Pace External Pacemaker Analyzer Model #1000Dni Nevada, Inc. · 2001 · cites it directly0descendants
  • K954391Models Qed-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load…Bio-Tek Instruments, Inc. · 1995 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K903966External Pacemaker Analyzer Model Pma-1Bio-Tek Instruments, Inc.1991—
+1K011729Sigma Pace External Pacemaker Analyzer Model #1000Dni Nevada, Inc.2001—
+1K954391Models Qed-6, 6M and 6H Defibrillator Analyzer with Optional Universal…Bio-Tek Instruments, Inc.1995—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199510
200110
FIG. 1 — Lineage of K903966, 1991–2001Source: 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 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K011729Sigma Pace External Pacemaker Analyzer Model #1000Dni Nevada, Inc.20010
K954391Models Qed-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load…Bio-Tek Instruments, Inc.19950

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, K011729 (Dni Nevada, Inc., 2001) has gone furthest, with 0 descendants of its own.

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—

More from Bio-Tek Instruments, Inc.

37 FDA decisions under this applicant name. See the company

  • K973609Ida-4 and Ipt-MCBio-Tek Instruments, Inc. · 1997
  • K971273Index 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F, Cardiosat 100EFBio-Tek Instruments, Inc. · 1997
  • K961862Models Ida-2 Plus and Ipt-1Bio-Tek Instruments, Inc. · 1997
  • K954391Models Qed-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load AdapterBio-Tek Instruments, Inc. · 1995
  • K953710ELX808 Automated Microplate ReadersBio-Tek Instruments, Inc. · 19951 recall

Recent decisions in DTC

The DTC category page

  • K170815PSA CableBoston Scientific Corporation · 2017
  • K083674PK-141 Patient CableBiotronik, Inc. · 2009
  • K011729Sigma Pace External Pacemaker Analyzer Model #1000Dni Nevada, Inc. · 2001
  • K002497Model 4810 Analyzer Output AdapterPace Medical · 2000
  • K961582External Pacemaker Analyzer, Model PMT 100North American Technical Services Corp. · 1996

https://510kreport.com/device/K903966 · printed Nov 6, 2026

Cite this page

510(k) Report. “K903966: External Pacemaker Analyzer Model Pma-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903966

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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