# K051534: Cardioline AR 600, AR 1200, AR 2100

- Pathway: 510(k) (Special)
- Applicant: Et Medical Devices Spa
- Decided: Oct 5, 2005 after 117 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002074 (2000). 1 ancestor in all.
17 later devices descend from it; 5 cite it directly.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002074: AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View Hes, H&C Medical Devices Spa (2000) Summary page 1.

## Most influential descendants
- K082124: Carditte Microtel (2009), 12 descendants of its own
- K091505: COR12+ (2009), 6 descendants of its own
- K150810: Vyntus / SentrySuite Product Line (2015), 5 descendants of its own
- K150289: Cardioline HD+ (2015), 3 descendants of its own
- K181524: Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART (2018), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K051534
Methodology: https://510kreport.com/methodology