510(k) Report

510(k) · Cleared

Cleared

Cardioline AR 600, AR 1200, AR 2100

K051534510(k) SpecialCleared Oct 5, 2005117-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

Et Medical Devices Spa · DPS Electrocardiograph

Cleared on Oct 5, 2005 as substantially equivalent to K002074 (H&C Medical Devices Spa, 2000) after a 117-day review. Its family tree reaches back 1 generation to 2000. 1 of the 19 devices in its family, counting itself, has a Class I recall. 17 later devices descend from it.

Decided
Oct 5, 2005
Review
117 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K002074 (2000). 17 later devices descend from it, 5 citing it directly. 1 of the 19 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2010: 1 descendant cleared2009: 3 descendants cleared2011: 1 descendant cleared2016: 2 descendants cleared2015: 2 descendants cleared, 1 with a Class I recall12013: 1 descendant cleared2023: 2 descendants cleared2018: 3 descendants cleared2019: 2 descendants clearedK002074 · AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View Hes · H&C Medical Devices Spa · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants, 1 with a Class I recall14 generations forward: 4 descendants5 generations forward: 1 descendant K002074 · AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View Hes · H&C Medical Devices Spa · 20000+5
  1. Root · 1 generation backK002074 AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View HesH&C Medical Devices Spa · 2000
  2. This deviceK051534 Cardioline AR 600, AR 1200, AR 2100Et Medical Devices Spa · 2005
  3. Descendant · cites it directly · 12 of its ownK082124 Carditte MicrotelEt Medical Devices Spa · 2009
  4. Descendant · 2 generations on · 6 of its ownK091505 COR12+Viasys Healthcare GmbH · 2009
  5. Descendant · 3 generations on · 5 of its ownK150810 Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · Recalled (Class I)
  6. Descendant · 2 generations on · 3 of its ownK150289 Cardioline HD+Cardioline S.P.A · 2015
  7. Descendant · 4 generations on · 1 of its ownK181524 Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with…Vyaire Medical, Inc. · 2018

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2009: 32010: 12011: 12013: 12015: 22016: 22018: 32019: 22023: 2
2009high 3 (2009) · low 0 (2012)2026

Class I recalls in this family

  • K150810 Vyntus / SentrySuite Product Line3 generations on · 2015

Most influential descendants

Showing 5 of 17 · See all
  • K082124Carditte MicrotelEt Medical Devices Spa · 2009 · cites it directly12descendants
  • K091505COR12+Viasys Healthcare GmbH · 2009 · 2 generations on6descendants
  • K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · 3 generations on5descendants
  • K150289Cardioline HD+Cardioline S.P.A · 2015 · 2 generations on3descendants
  • K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…Vyaire Medical, Inc. · 2018 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002074AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View HesH&C Medical Devices Spa2000—
0 (this device)K051534Cardioline AR 600, AR 1200, AR 2100Et Medical Devices Spa2005—
+1K082124Carditte MicrotelEt Medical Devices Spa2009—
+2K091505COR12+Viasys Healthcare GmbH2009—
+3K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH2015Class I
+2K150289Cardioline HD+Cardioline S.P.A2015—
+4K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with…Vyaire Medical, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200930
201010
201110
201310
201521
201620
201830
201920
202320
FIG. 1 — Lineage of K051534, 2000–2023Source: 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.

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
Get a 510(k) Report

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
*K002074AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View Hes
Summary page 1
…ich has been modified is: Manufacturer Name Applicant Name Predicate Device 510(k) Number Elettronica Trentina H&C Medical AB CARDIETTE K002074 spa (*) Devices spa (0) Daedalus View base and Hes (*) name c…
H&C Medical Devices Spa2000—

Also cleared against K002074: 3 other devices →

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K082124Carditte MicrotelEt Medical Devices Spa200912
K093211Carecenter MDCardiac Science Corporation20101
K160840ECG100+, ECG200+Cardioline S.P.A20160
K113234Mobcardio SystemMobhealth Incorporation20110
K090936Single-Channel Handheld Electrocardiograph, Model ECG80AContec Medical System Co., Ltd.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 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K082124 (Et Medical Devices Spa, 2009) has gone furthest, with 12 descendants of its own.
  • 3 other devices also cite its predicate K002074.

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?

CARDIOLINE AR 600 and AR 1200 and AR 2100 are a family of electrocardiograph recorders provided with a program for automated ecg analysis and with a graphic LCD display. The equipments are intended for use in routine ecg recording in physician practice and/or hospital. The electrical heart activity is detected by means of two or more electrocardiograph electrodes and is recorded on thermal paper. Intended use for non interpretive applications covers the…

Read the full statement (162 words)

CARDIOLINE AR 600 and AR 1200 and AR 2100 are a family of electrocardiograph recorders provided with a program for automated ecg analysis and with a graphic LCD display.

The equipments are intended for use in routine ecg recording in physician practice and/or hospital. The electrical heart activity is detected by means of two or more electrocardiograph electrodes and is recorded on thermal paper.

Intended use for non interpretive applications covers the full range of patient population with no limitations with respect to age, sex and race of the patient.

The interpretation program is intended to provide a diagnostic support to the physician for the ecg evaluation on rhythm and morphology.

Interpretation Statements must be overviewed and approved by trained Physician's. Interpretation statements just represent a partial qualitative and quantitative information of the general patient cardiovascular condition: no therapy or drugs can be subministrated based solely on Interpretation statements.

The equipments are intended to be used by trained medical personnel or physician's.

Indications for use as stated in the FDA summary.

Also cleared against K002074

3 other devices cite the same predicate.

  • K091397Ecscope 200Dyansys, Inc. · 2009
  • K070614CorscreenViasys Healthcare GmbH · 2007
  • K024283Cardiodirect, Models 12M, 12I, 12SReynolds Medical, Ltd. · 2003

More from Et Medical Devices Spa

3 FDA decisions under this applicant name. See the company

  • K091054WALK400HEt Medical Devices Spa · 2009
  • K082124Carditte MicrotelEt Medical Devices Spa · 2009

Recent decisions in DPS

The DPS category page

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  • K260005MyoVista wavECG (DG-200-B15-003)HeartSciences, Inc. · 2026
  • K260250QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)QT Medical, Inc. · 2026
  • K254255S-Patch CardioAIWellysis Corp. · 2026
  • K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc. · 2026

https://510kreport.com/device/K051534 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051534: Cardioline AR 600, AR 1200, AR 2100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051534

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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