510(k) Report

510(k) · Cleared

Cleared

Hardware:Cardio Perfect Portable, Cardio Perfect MD and Software:Cardio Perfect (V. 4.0 and UP for Dos), Cardio Perfect

K962854510(k) TraditionalCleared Jan 27, 1997189-day review

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

Cardio Control BV · LOS (no longer in FDA’s product-code list)

Cleared on Jan 27, 1997 after a 189-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 11 later devices descend from it.

Decided
Jan 27, 1997
Review
189 days
Product code
LOS
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 1 descendant cleared2009: 2 descendants cleared2015: 2 descendants cleared2014: 2 descendants cleared2017: 1 descendant cleared2011: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant cleared1995200020052010201520202025
  1. This deviceK962854 Hardware:Cardio Perfect Portable, Cardio Perfect MD and…Cardio Control BV · 1997
  2. Descendant · cites it directly · 10 of its ownK052158 Welch Allyn Cardioperfect Workstation Version 1.5.0 SoftwareWelch Allyn, Inc. · 2005
  3. Descendant · 2 generations on · 4 of its ownK082478 Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62Welch Allyn, Inc. · 2009
  4. Descendant · 3 generations on · 2 of its ownK141546 Vitalograph Model 7000 SpirotracVitalograph (Ireland), Ltd. · 2014
  5. Descendant · cites it directly · 1 of its ownK090602 Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp. · 2009
  6. Descendant · 4 generations on · 0 of its ownK201562 SpirotracVitalograph Ireland, Ltd. · 2020

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2005: 12009: 22011: 12014: 22015: 22017: 12019: 12020: 1
2005high 2 (2009) · low 0 (2006)2026

Most influential descendants

Showing 5 of 11 · See all
  • K052158Welch Allyn Cardioperfect Workstation Version 1.5.0 SoftwareWelch Allyn, Inc. · 2005 · cites it directly10descendants
  • K082478Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62Welch Allyn, Inc. · 2009 · 2 generations on4descendants
  • K141546Vitalograph Model 7000 SpirotracVitalograph (Ireland), Ltd. · 2014 · 3 generations on2descendants
  • K090602Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp. · 2009 · cites it directly1descendant
  • K201562SpirotracVitalograph Ireland, Ltd. · 2020 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962854Hardware:Cardio Perfect Portable, Cardio Perfect MD and Software:Cardio…Cardio Control BV1997—
+1K052158Welch Allyn Cardioperfect Workstation Version 1.5.0 SoftwareWelch Allyn, Inc.2005—
+2K082478Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62Welch Allyn, Inc.2009—
+3K141546Vitalograph Model 7000 SpirotracVitalograph (Ireland), Ltd.2014—
+1K090602Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp.2009—
+4K201562SpirotracVitalograph Ireland, Ltd.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200920
201110
201420
201520
201710
201910
202010
FIG. 1 — Lineage of K962854, 1997–2020Source: 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 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K052158Welch Allyn Cardioperfect Workstation Version 1.5.0 SoftwareWelch Allyn, Inc.200510
K090602Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp.20091

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, K052158 (Welch Allyn, Inc., 2005) has gone furthest, with 10 descendants of its own.

More from Cardio Control BV

4 FDA decisions under this applicant name. See the company

  • K935732Cardio Perfect ST 2001Cardio Control BV · 1996
  • K922898Cardio Perfect, Cardio Perfect MDCardio Control BV · 1993
  • K913374Cardio Perfect, Cardio Perfect MDCardio Control BV · 1992

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/K962854 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962854: Hardware:Cardio Perfect Portable, Cardio Perfect MD and Software:Cardio Perfect (V. 4.0 and UP for Dos), Cardio Perfect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962854

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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