510(k) · Cleared
ClearedMPM System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aerotel Medical Systems, Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Oct 6, 2004 as substantially equivalent to K020534 (Cybernet Medical, 2003) and 3 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1994. 8 later devices descend from it.
- Decided
- Oct 6, 2004
- Review
- 90 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K930314 (1994). 9 ancestors in all, the oldest K915632 (1992). 8 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK930314 Heartline Transtelephonic Ecg Receiving ConsoleAerotel, Ltd. · 1994
- 3 generations backK983717 BP-Tel Trans-Telephonic Blood Pressure Measurement SystemAerotel Medical Systems (1998), Ltd. · 1999
- 2 generations backK021447 Tele-Cliniq Data Transmission System Blood Pressure Measurement SystemAerotel Medical Systems (1998), Ltd. · 2002
- 1 generation backK030825 MPM-NetAerotel Medical Systems (1998), Ltd. · 2003
- This deviceK041854 MPM SystemAerotel Medical Systems, Ltd. · 2004
- Descendant · cites it directly · 7 of its ownK051544 Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc. · 2005
- Descendant · 2 generations on · 4 of its ownK063008 Health Check KioskXperex Corporation · 2007
- Descendant · 2 generations on · 1 of its ownK151839 AMC Health VitalCaregiving SystemAmc Health · 2016
- Descendant · 3 generations on · 1 of its ownK101198 Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK233446 AMC Health CareConsoleAmc Health · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K051544Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc. · 2005 · cites it directly7descendants
- K063008Health Check KioskXperex Corporation · 2007 · 2 generations on4descendants
- K151839AMC Health VitalCaregiving SystemAmc Health · 2016 · 2 generations on1descendant
- K101198Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc. · 2010 · 3 generations on1descendant
- K233446AMC Health CareConsoleAmc Health · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930314 | Heartline Transtelephonic Ecg Receiving Console | Aerotel, Ltd. | 1994 | — |
| −3 | K983717 | BP-Tel Trans-Telephonic Blood Pressure Measurement System | Aerotel Medical Systems (1998), Ltd. | 1999 | — |
| −2 | 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 | — |
| 0 (this device) | K041854 | MPM System | Aerotel Medical Systems, Ltd. | 2004 | — |
| +1 | K051544 | Vitalcaregiving System | Advanced Monitoring Caregiving, Inc. | 2005 | — |
| +2 | K063008 | Health Check Kiosk | Xperex Corporation | 2007 | — |
| +2 | K151839 | AMC Health VitalCaregiving System | Amc Health | 2016 | — |
| +3 | K101198 | Csi Managed Health System Model: Csi Model 9K | Computerized Screening, Inc. | 2010 | — |
| +2 | K233446 | AMC Health CareConsole | Amc Health | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K020534 | Medstar System, Models 533-300Summary page 1…Access. Classification name: Telephone electrocardiograph transmitter and receiver. (3) Equivalent legally-marketed devices. 1. Cybernet Medical Medstar, K020534 2. Aerotel BPTEL/MPM, K983717 3. Aerotel TeleCliniQ, K021447 4. Aerotel MPMP-Net, K030825 (4) Description… | 2003 |
| * | K983717 | BP-Tel Trans-Telephonic Blood Pressure Measurement SystemSummary page 1…elephone electrocardiograph transmitter and receiver. (3) Equivalent legally-marketed devices. 1. Cybernet Medical Medstar, K020534 2. Aerotel BPTEL/MPM, K983717 3. Aerotel TeleCliniQ, K021447 4. Aerotel MPMP-Net, K030825 (4) Description… | 1999 |
| * | K021447 | Tele-Cliniq Data Transmission System Blood Pressure Measurement SystemSummary page 1…r and receiver. (3) Equivalent legally-marketed devices. 1. Cybernet Medical Medstar, K020534 2. Aerotel BPTEL/MPM, K983717 3. Aerotel TeleCliniQ, K021447 4. Aerotel MPMP-Net, K030825 (4) Description… | 2002 |
| * | K030825 | MPM-NetSummary page 1…lly-marketed devices. 1. Cybernet Medical Medstar, K020534 2. Aerotel BPTEL/MPM, K983717 3. Aerotel TeleCliniQ, K021447 4. Aerotel MPMP-Net, K030825 (4) Description… | 2003 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051544 | Vitalcaregiving System | 2005 | 7 |
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 10 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K051544 (Advanced Monitoring Caregiving, Inc., 2005) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K020534.
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 MPM SYSTEM is indicated when patients use with home patient monitoring devices (blood pressure, digital scale, blood glucose level, respiratory peak flow, pulse oximetry) and wish to send the measured data to a central station via modem by telephone, where reports can be generated for the physician and reports can be received over the Internet by physicians and patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041854: MPM System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041854
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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