510(k) Report

510(k) · Cleared

Cleared

Cardiosoft PC Ecg, Usb Version

K052295510(k) TraditionalCleared Jan 13, 2006143-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

Cardiosoft, L.P. · DPS Electrocardiograph

Cleared on Jan 13, 2006 as substantially equivalent to K924544 (Fairlake Marketing Group, Inc., 1993) after a 143-day review. Its family tree reaches back 1 generation to 1993.

Decided
Jan 13, 2006
Review
143 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K924544 (1993). No later device cites it as a predicate yet.

K924544 · Cardiax · Fairlake Marketing Group, Inc. · 19931990199520002005
K924544 · Cardiax · Fairlake Marketing Group, Inc. · 19930
  1. Root · 1 generation backK924544 CardiaxFairlake Marketing Group, Inc. · 1993
  2. This deviceK052295 Cardiosoft PC Ecg, Usb VersionCardiosoft, L.P. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K924544CardiaxFairlake Marketing Group, Inc.1993—
0 (this device)K052295Cardiosoft PC Ecg, Usb VersionCardiosoft, L.P.2006—
FIG. 1 — Lineage of K052295, 1993–2006Source: 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
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What was it cleared against? (1)

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
*K924544Cardiax
Summary page 1
…tablishment Registration No.: 3003786840 Predicate Device(s): The CardioSoft PC ECG is substantially equivalent to the CARDIAX device, K924544 (Imed I Fairlake Marketing Group) [predicated on the MICROMED QRS-CARDJ, cleared…
Fairlake Marketing Group, Inc.1993—

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?

  • Its one ancestor has no recall.

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 CardioSoft PC ECG is intended for use in acquiring, processing, recording, archiving and displaying electrocardiographic information. It can provide serial comparison of ECG information to facilitate review of current and previous records and is intended for use by trained operators. The system offers no diagnostic opinion to the user, but may be used by a physician to render his or her own medical opinion.

Indications for use as stated in the FDA summary.

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https://510kreport.com/device/K052295 · printed Nov 4, 2026

Cite this page

510(k) Report. “K052295: Cardiosoft PC Ecg, Usb Version.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052295

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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