510(k) · Cleared
ClearedBP-Tel Trans-Telephonic Blood Pressure Measurement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aerotel Medical Systems (1998), Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Sep 16, 1999 as substantially equivalent to K930314 (Aerotel, Ltd., 1994) and 1 other predicate after a 330-day review. Its family tree reaches back 1 generation to 1994. 11 later devices descend from it.
- Decided
- Sep 16, 1999
- Review
- 330 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930314 (1994). 2 ancestors in all. 11 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK930314 Heartline Transtelephonic Ecg Receiving ConsoleAerotel, Ltd. · 1994
- This deviceK983717 BP-Tel Trans-Telephonic Blood Pressure Measurement SystemAerotel Medical Systems (1998), Ltd. · 1999
- Descendant · cites it directly · 10 of its ownK021447 Tele-Cliniq Data Transmission System Blood Pressure Measurement SystemAerotel Medical Systems (1998), Ltd. · 2002
- Descendant · cites it directly · 9 of its ownK030825 MPM-NetAerotel Medical Systems (1998), Ltd. · 2003
- Descendant · cites it directly · 8 of its ownK041854 MPM SystemAerotel Medical Systems, Ltd. · 2004
- Descendant · 2 generations on · 7 of its ownK051544 Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc. · 2005
- Descendant · 3 generations on · 4 of its ownK063008 Health Check KioskXperex Corporation · 2007
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K021447Tele-Cliniq Data Transmission System Blood Pressure Measurement SystemAerotel Medical Systems (1998), Ltd. · 2002 · cites it directly10descendants
- K030825MPM-NetAerotel Medical Systems (1998), Ltd. · 2003 · cites it directly9descendants
- K041854MPM SystemAerotel Medical Systems, Ltd. · 2004 · cites it directly8descendants
- K051544Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc. · 2005 · 2 generations on7descendants
- K063008Health Check KioskXperex Corporation · 2007 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930314 | Heartline Transtelephonic Ecg Receiving Console | Aerotel, Ltd. | 1994 | — |
| 0 (this device) | K983717 | BP-Tel Trans-Telephonic Blood Pressure Measurement System | Aerotel Medical Systems (1998), Ltd. | 1999 | — |
| +1 | K021447 | Tele-Cliniq Data Transmission System Blood Pressure Measurement System | Aerotel Medical Systems (1998), Ltd. | 2002 | — |
| +1 | K030825 | MPM-Net | Aerotel Medical Systems (1998), Ltd. | 2003 | — |
| +1 | K041854 | MPM System | Aerotel Medical Systems, Ltd. | 2004 | — |
| +2 | K051544 | Vitalcaregiving System | Advanced Monitoring Caregiving, Inc. | 2005 | — |
| +3 | K063008 | Health Check Kiosk | Xperex Corporation | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 1 | 0 |
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.
Planning a device in DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K930314 | Heartline Transtelephonic Ecg Receiving ConsoleSummary page 1…r and Associated Electronics, 74 KGJ. (3) Equivalent legally-marketed devices. 1. UA 767 Home Blood Pressure System,’ : 2. Aecrotel Central System for Event Recorders, K93 0314 3. Aerotel ECG HeartView Cardiac Event recorder, K950004 (4) Description Aerotel BP-Tel Page AS The system incl… | 1994 |
| * | K950004 | Heartview (TM) 12-Lead Electrocardiograph Recorder/TransmitterSummary page 1…lly-marketed devices. 1. UA 767 Home Blood Pressure System,’ : 2. Aecrotel Central System for Event Recorders, K93 0314 3. Aerotel ECG HeartView Cardiac Event recorder, K950004 (4) Description Aerotel BP-Tel Page AS The system includes a home blood-pressure measuring device that makes us… | 1995 |
| * | — | UA 767 Home Blood Pressure System Named without a submission number |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983717 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983717: BP-Tel Trans-Telephonic Blood Pressure Measurement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983717
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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