510(k) Report

510(k) · Cleared

Cleared

AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View Hes

K002074510(k) TraditionalCleared Oct 4, 200086-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

H&C Medical Devices Spa · DPS Electrocardiograph

Cleared on Oct 4, 2000 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 28 devices in its family, counting itself, has a Class I recall. 27 later devices descend from it.

Decided
Oct 4, 2000
Review
86 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
0

27 later devices descend from it, 4 citing it directly. 1 of the 28 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2007: 1 descendant cleared2005: 1 descendant cleared2003: 1 descendant cleared2009: 4 descendants cleared2010: 1 descendant cleared2008: 3 descendants cleared2006: 1 descendant cleared2011: 1 descendant cleared2016: 2 descendants cleared2015: 2 descendants cleared, 1 with a Class I recall12013: 1 descendant cleared2021: 1 descendant cleared2023: 2 descendants cleared2018: 3 descendants cleared2019: 2 descendants cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK002074 AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View HesH&C Medical Devices Spa · 2000
  2. Descendant · cites it directly · 17 of its ownK051534 Cardioline AR 600, AR 1200, AR 2100Et Medical Devices Spa · 2005
  3. Descendant · 2 generations on · 12 of its ownK082124 Carditte MicrotelEt Medical Devices Spa · 2009
  4. Descendant · cites it directly · 12 of its ownK070614 CorscreenViasys Healthcare GmbH · 2007
  5. Descendant · 2 generations on · 10 of its ownK080734 Flowscreen, Flowscreen/Corscreen, Flowscreen CTViasys Healthcare GmbH · 2008
  6. Descendant · 3 generations on · 9 of its ownK082539 Masterscope, Masterscope Ecg, Masterscope CTCardinal Health Germany 234 GmbH · 2008

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12006: 12007: 12008: 32009: 42010: 12011: 12013: 12015: 22016: 22018: 32019: 22021: 12023: 22024: 1
2003high 4 (2009) · low 0 (2004)2026

Class I recalls in this family

  • K150810 Vyntus / SentrySuite Product Line4 generations on · 2015

Most influential descendants

Showing 5 of 27 · See all
  • K051534Cardioline AR 600, AR 1200, AR 2100Et Medical Devices Spa · 2005 · cites it directly17descendants
  • K082124Carditte MicrotelEt Medical Devices Spa · 2009 · 2 generations on12descendants
  • K070614CorscreenViasys Healthcare GmbH · 2007 · cites it directly12descendants
  • K080734Flowscreen, Flowscreen/Corscreen, Flowscreen CTViasys Healthcare GmbH · 2008 · 2 generations on10descendants
  • K082539Masterscope, Masterscope Ecg, Masterscope CTCardinal Health Germany 234 GmbH · 2008 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002074AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View HesH&C Medical Devices Spa2000—
+1K051534Cardioline AR 600, AR 1200, AR 2100Et Medical Devices Spa2005—
+2K082124Carditte MicrotelEt Medical Devices Spa2009—
+1K070614CorscreenViasys Healthcare GmbH2007—
+2K080734Flowscreen, Flowscreen/Corscreen, Flowscreen CTViasys Healthcare GmbH2008—
+3K082539Masterscope, Masterscope Ecg, Masterscope CTCardinal Health Germany 234 GmbH2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200610
200710
200830
200940
201010
201110
201310
201521
201620
201830
201920
202110
202320
202410
FIG. 1 — Lineage of K002074, 2000–2024Source: 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.

1 device in this family has a Class I recall. 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K051534Cardioline AR 600, AR 1200, AR 2100Et Medical Devices Spa200517
K070614CorscreenViasys Healthcare GmbH200712
K024283Cardiodirect, Models 12M, 12I, 12SReynolds Medical, Ltd.20034
K091397Ecscope 200Dyansys, Inc.20090

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K051534 (Et Medical Devices Spa, 2005) has gone furthest, with 17 descendants of its own.

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—

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https://510kreport.com/device/K002074 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002074: AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View Hes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002074

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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