510(k) Report

510(k) · Cleared

Cleared

CT 100 Electrocardiograph

K981951510(k) TraditionalCleared Jul 28, 199890-day reviewClass II21 CFR 870.2340

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

Macquarie Medical Systems · DPS Electrocardiograph

Cleared on Jul 28, 1998 as substantially equivalent to K946205 (Schiller America, Inc., 1995) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1991.

Decided
Jul 28, 1998
Review
90 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K904032 (1991). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestorK904032 · Elite II Electrocardiograph · Burdick Corp. · 1991199019921994199619982000
Other ancestors, by generation 1 generation back: 1 other ancestor K904032 · Elite II Electrocardiograph · Burdick Corp. · 19910
  1. Root · 1 generation backK904032 Elite II ElectrocardiographBurdick Corp. · 1991
  2. This deviceK981951 CT 100 ElectrocardiographMacquarie Medical Systems · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K904032Elite II ElectrocardiographBurdick Corp.1991—
0 (this device)K981951CT 100 ElectrocardiographMacquarie Medical Systems1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
FIG. 1 — Lineage of K981951, 1991–1998Source: 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), 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 DPS? 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 DPS device

  1. #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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
*K946205Cardiovit at-1, P-80
Summary page 1
…ECG monitor, ECG recorder, and others. Proprietary Name: CT 100 Electrocardiograph D. Classification Number: 74DPS E. Substantial Equivalence: Schiller Cardiovit AT-1 (K946205), Burdick Elite II (K904032), and others. F. Device Description: The device is a battery-operated, portable, 12 lead electrocard…
Schiller America, Inc.1995—
*K904032Elite II Electrocardiograph
Summary page 1
…nd others. Proprietary Name: CT 100 Electrocardiograph D. Classification Number: 74DPS E. Substantial Equivalence: Schiller Cardiovit AT-1 (K946205), Burdick Elite II (K904032), and others. F. Device Description: The device is a battery-operated, portable, 12 lead electrocardiograph which produces a sin…
Burdick Corp.1991—

Also cleared against K946205: 1 other device →

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.
  • 1 other device also cites its predicate K946205.

How does its category compare?

All DPS devices

DPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPS

6in 2025

2007: 112008: 132009: 142010: 112011: 222012: 122013: 102014: 112015: 82016: 112017: 92018: 142019: 32020: 62021: 52022: 62023: 102024: 82025: 62026 (partial year): 6
2007high 22 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPS

163in 2025

2007: 87 days median2008: 31 days median2009: 84 days median2010: 104 days median2011: 154 days median2012: 117 days median2013: 134 days median2014: 253 days median2015: 178 days median2016: 229 days median2017: 177 days median2018: 221 days median2019: 178 days median2020: 224 days median2021: 135 days median2022: 244 days median2023: 236 days median2024: 260 days median2025: 163 days median2026 (partial year): 258 days median
2007high 260 (2024) · low 31 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DPS

3in 2025

2007: 22009: 12010: 22011: 12019: 92020: 22021: 12022: 12023: 32024: 4, 1 Class I2025: 32026 (partial year): 4
2007high 9 (2019) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DPS

55in 2025

2007: 92008: 172009: 142010: 212011: 1212012: 562013: 152014: 152015: 302016: 122017: 152018: 192019: 272020: 592021: 242022: 592023: 542024: 642025: 55
2007high 121 (2011) · low 9 (2007)2025

MAUDE reports naming product code DPS, 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
2007118729
20081331017
20091484114
201011104221
2011221541121
201212117056
201310134015
201411253015
20158178030
201611229012
20179177015
201814221019
20193178927
20206224259
20215135124
20226244159
202310236354
202482604 (1)64
20256163355
202662584—

What is it indicated for?

The device is intended for use as a diagmostic device which receives, records, and produces a visual display of the electrical signal produced by the heart.

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

Also cleared against K946205

1 other device cites the same predicate.

  • K961798CT 200 ElectrocardiographMacquarie Medical Systems · 1998

More from Macquarie Medical Systems

2 FDA decisions under this applicant name. See the company

  • K961798CT 200 ElectrocardiographMacquarie Medical Systems · 1998

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https://510kreport.com/device/K981951 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981951: CT 100 Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981951

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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