# K983717: BP-Tel Trans-Telephonic Blood Pressure Measurement System

- Pathway: 510(k) (Traditional)
- Applicant: Aerotel Medical Systems (1998), Ltd.
- Decided: Sep 16, 1999 after 330 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- 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 K930314 (1994). 2 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930314: Heartline Transtelephonic Ecg Receiving Console, Aerotel, Ltd. (1994) Summary page 1.
- K950004: Heartview (TM) 12-Lead Electrocardiograph Recorder/Transmitter, Aerotel, Ltd. (1995) Summary page 1.
- (no number) UA 767 Home Blood Pressure System: named in the summary without a submission number

## Most influential descendants
- K021447: Tele-Cliniq Data Transmission System Blood Pressure Measurement System (2002), 10 descendants of its own
- K030825: MPM-Net (2003), 9 descendants of its own
- K041854: MPM System (2004), 8 descendants of its own
- K051544: Vitalcaregiving System (2005), 7 descendants of its own
- K063008: Health Check Kiosk (2007), 4 descendants of its own

## Indications for use
The Aerotel Medical Systems (1998) Ltd BP-Tel Trans-Telephonic Monitoring system is intended to be used by patients to measure their blood pressure at home and transmit it to a central station by telephone. The system includes both the patient unit and a central computer program (to be used in a Personal Computer) which receives the blood pressure data, stores it in a patient's record, and prepares reports and charts showing the history of the systolic, diastolic pressures and the heart rate. The BP-Tel is not intended for patients with defibrillators.

Source page: https://510kreport.com/device/K983717
Methodology: https://510kreport.com/methodology