510(k) · Cleared
ClearedQRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card Usb
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulse Biomedical, Inc. · DPS Electrocardiograph
Cleared on Jul 23, 2010 as substantially equivalent to K972255 (Pulse Biomedical, Inc., 1998) and 3 other predicates after a 122-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.
- Decided
- Jul 23, 2010
- Review
- 122 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K942704 (1994). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK942704 Card Guard, Model CG-7000D Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 1994
- 3 generations backK993799 CG-7000DX Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 1999
- 2 generations backK052556 CG-7000DX-BT Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 2006
- 1 generation backK082077 BT3/6, BT12Corscience GmbH & Co. KG · 2008
- This deviceK100813 QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS…Pulse Biomedical, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK142352 CardiacLinxRoss Medical Technology, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K142352CardiacLinxRoss Medical Technology, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942704 | Card Guard, Model CG-7000D Ecg Recorder/Transmitter | Card Guard Scientific Survival, Ltd. | 1994 | — |
| −3 | K993799 | CG-7000DX Ecg Recorder/Transmitter | Card Guard Scientific Survival, Ltd. | 1999 | — |
| −2 | K052556 | CG-7000DX-BT Ecg Recorder/Transmitter | Card Guard Scientific Survival, Ltd. | 2006 | — |
| −1 | K082077 | BT3/6, BT12 | Corscience GmbH & Co. KG | 2008 | — |
| 0 (this device) | K100813 | QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card Usb | Pulse Biomedical, Inc. | 2010 | — |
| +1 | K142352 | CardiacLinx | Ross Medical Technology, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
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 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K972255 | Pulse Biomedical Inc, QRS Card S-T Segment Analysis Monitoring SystemSummary page 2…16039 Special 510(k) - QRS CardTM S-T Segment Analysis Patient Monitoring System Modification Legally Marketed Devices-to W-hich Substantial ]Equivalence is Claimed K972255 QRS CARDTM S-T Segment Pulse Bio Medical Inc. Analysis Patie… | 1998 |
| * | K080141 | PC Ecg 1200W SystemSummary page 2…Analysis Patient Monitoring System _ _ _ _ _ _ _ _ _ _ _ _ _ K080141 PC ECG 1200W System Norav Medical LTD K06 1977 Plex 04 Wireless.… | 2008 |
| * | K061977 | Pelex-04 Wireless Electrocardiograph with Software AccessoriesSummary page 2…_ _ _ _ _ _ _ _ _ _ _ _ _ K080141 PC ECG 1200W System Norav Medical LTD K06 1977 Plex 04 Wireless. PinMed, Inc. Electrocardiograph with… | 2006 |
| * | K082077 | BT3/6, BT12Summary page 2…Plex 04 Wireless. PinMed, Inc. Electrocardiograph with Software Accessories K082077 BR3/6, BR12 Coscience GmbH & Co KG Device Description: The QRS CARDTM S-T Segme… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142352 | CardiacLinx | 2015 | 0 |
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K142352 (Ross Medical Technology, Inc., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
This device is intended for use as a patient monitor for any patient undergoing ECG S-T Segment Analysis and/or ECG stress analysis during rest or exercise. Exercise can be performed treadmill or bicycle ergometer use. The intended use locations are either in a physician's office, hospital or 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 a hospital environment, physician's office, or similar settings. This device is not intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100813: QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card Usb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100813
Report an extraction error
Are you the manufacturer?
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