# K082124: Carditte Microtel

- Pathway: 510(k) (Special)
- Applicant: Et Medical Devices Spa
- Decided: Feb 19, 2009 after 206 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: 2 generations back to K002074 (2000). 2 ancestors in all.
12 later devices descend from it; 3 cite it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051534: Cardioline AR 600, AR 1200, AR 2100, Et Medical Devices Spa (2005) Summary page 2.

## Most influential descendants
- 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
- K223670: MESI mTablet ECG Diagnostic System, MESI mTablet ECG (2023), 0 descendants of its own

## Indications for use
cardiette microtei is a 12 lead ECG acquirer fitted with a display and keyboait The electrical hear activity is detected by means of two or more eiectrocardio?!h eaectrnde- ard the devicecan acquire and transmit an ECG trace in analogue (via sound coupling).or'digitatformat (USB port or via the wireless Bluetooth channel) to a remote PC. The equipments are intended for use in routine ecg recording in physician practice and/or hospital. 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 equipment is intended to be used by trained medical personnel or physicians. cardiette microtel does not include ecg interpretation tools and/or analysis programs. The device is intended to transmit ECG waveforms to a PC. Analysis program on a PC is a separate product not marketed with the Cardiette Microtel. The hardware and the software of the equipment, except for the paper recorder routines and interpretation program, are the same of the predicated device. Indication for: use of cardiette microtel has not been changed, except for the ecg interpretation program not present on this device, with respect to the predicate device CARDIOLINE AR600, AR1200, AR2100 (ref. K051534 CARDIOLINE AR600, AR1200, AR2100).

Source page: https://510kreport.com/device/K082124
Methodology: https://510kreport.com/methodology