510(k) Report

510(k) · Cleared

Cleared

Pulse Biomedical Inc, QRS Card S-T Segment Analysis Monitoring System

K972255510(k) TraditionalCleared Jul 7, 1998385-day review

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

Pulse Biomedical, Inc. · LOS (no longer in FDA’s product-code list)

Cleared on Jul 7, 1998 after a 385-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided
Jul 7, 1998
Review
385 days
Product code
LOS
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2015: 1 descendant cleared1995200020052010201520202025
  1. This deviceK972255 Pulse Biomedical Inc, QRS Card S-T Segment Analysis Monitoring SystemPulse Biomedical, Inc. · 1998
  2. Descendant · cites it directly · 1 of its ownK100813 QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS…Pulse Biomedical, Inc. · 2010
  3. Descendant · 2 generations on · 0 of its ownK142352 CardiacLinxRoss Medical Technology, Inc. · 2015

Most influential descendants

Showing 2 of 2 · See all
  • K100813QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card UsbPulse Biomedical, Inc. · 2010 · cites it directly1descendant
  • K142352CardiacLinxRoss Medical Technology, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K972255Pulse Biomedical Inc, QRS Card S-T Segment Analysis Monitoring SystemPulse Biomedical, Inc.1998—
+1K100813QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card UsbPulse Biomedical, Inc.2010—
+2K142352CardiacLinxRoss Medical Technology, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201510
FIG. 1 — Lineage of K972255, 1998–2015Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LOS? 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K100813QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card UsbPulse Biomedical, Inc.20101

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, K100813 (Pulse Biomedical, Inc., 2010) has gone furthest, with 1 descendant of its own.

What is it indicated for?

This device is intended for use as a patient monitor for any patient undergoing ECG ST Segment Analysis and/or ECG Stress Analysis during resting or exercise. Exercise can be performed during treadmill or bicycle ergometer use. This device is capable of performing automatic computerized ECG Interpretation during resting condition. This device does not support automatic ECG Interpretation for neonatal use. The intended use locations are either in a…

Read the full statement (121 words)

This device is intended for use as a patient monitor for any patient undergoing ECG ST Segment Analysis and/or ECG Stress Analysis during resting or exercise. Exercise can be performed during treadmill or bicycle ergometer use.

This device is capable of performing automatic computerized ECG Interpretation during resting condition. This device does not support automatic ECG Interpretation for

neonatal use.

The intended use locations are either in a physician office, hospital exercise rehabilitation facilities, or similar use areas. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in the hospital environment, physician’s office, or similar settings. This device is not intended for home use.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Pulse Biomedical, Inc.

3 FDA decisions under this applicant name. See the company

  • K100813QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card UsbPulse Biomedical, Inc. · 2010
  • K042799QRS-Card Cardiology SuitePulse Biomedical, Inc. · 2004

Recent decisions in LOS

The LOS category page

  • K090895Ekg-Plus II SoftwareBionet Co., Ltd. · 2009
  • K083749CARDIOVIEW32 Review ModuleQrs Diagnostic, LLC · 2009
  • K073376Philips Ecg AlgorithmPhilips Medical Systems · 2008
  • K023034Cardiotouch-3000Bionet Company, Ltd. · 2002
  • K011328Cardio Care Ekg-2000 12-Channel ElectrocardiographBionet Company, Ltd. · 2001

https://510kreport.com/device/K972255 · printed Nov 5, 2026

Cite this page

510(k) Report. “K972255: Pulse Biomedical Inc, QRS Card S-T Segment Analysis Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972255

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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