510(k) · Cleared
ClearedTele-Cliniq Data Transmission System 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 May 22, 2002 as substantially equivalent to K983717 (Aerotel Medical Systems (1998), Ltd., 1999) after a 16-day review. Its family tree reaches back 2 generations to 1994. 10 later devices descend from it.
- Decided
- May 22, 2002
- Review
- 16 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930314 (1994). 3 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK930314 Heartline Transtelephonic Ecg Receiving ConsoleAerotel, Ltd. · 1994
- 1 generation backK983717 BP-Tel Trans-Telephonic Blood Pressure Measurement SystemAerotel Medical Systems (1998), Ltd. · 1999
- This deviceK021447 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
- Descendant · 3 generations on · 1 of its ownK151839 AMC Health VitalCaregiving SystemAmc Health · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- 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
- K151839AMC Health VitalCaregiving SystemAmc Health · 2016 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930314 | Heartline Transtelephonic Ecg Receiving Console | Aerotel, Ltd. | 1994 | — |
| −1 | K983717 | BP-Tel Trans-Telephonic Blood Pressure Measurement System | Aerotel Medical Systems (1998), Ltd. | 1999 | — |
| 0 (this device) | 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 | — |
| +3 | K151839 | AMC Health VitalCaregiving System | Amc Health | 2016 | — |
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 |
|---|---|---|
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K983717 | BP-Tel Trans-Telephonic Blood Pressure Measurement SystemSummary page 1…for Blood Pressure Classification name: Monitor, Blood-Pressure, Amplifier and Associated Electronics, 74 KGJ. (3) Equivalent legally-marketed devices. Aerotel BP-Tel, K 983717 (4) Description N The system includes a home blood-pressure measuring device that makes use of the oscillpmetric system (purcha… | 1999 |
What descends from it? (10)
2 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K030825 (Aerotel Medical Systems (1998), Ltd., 2003) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K983717.
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 Tele-CliniQ Data Transmission 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 (purchased separately) 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. The Tele-CliniQ 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/K021447 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021447: Tele-Cliniq Data Transmission System Blood Pressure Measurement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021447
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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