510(k) · Cleared
ClearedHeartview (TM) 12-Lead Electrocardiograph Recorder/Transmitter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aerotel, Ltd. · DPS Electrocardiograph
Cleared on Oct 24, 1995 after a 294-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- Oct 24, 1995
- Review
- 294 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 3 citing it directly.
- This deviceK950004 Heartview (TM) 12-Lead Electrocardiograph Recorder/TransmitterAerotel, Ltd. · 1995
- Descendant · cites it directly · 11 of its ownK983717 BP-Tel Trans-Telephonic Blood Pressure Measurement SystemAerotel Medical Systems (1998), Ltd. · 1999
- Descendant · 2 generations on · 10 of its ownK021447 Tele-Cliniq Data Transmission System Blood Pressure Measurement SystemAerotel Medical Systems (1998), Ltd. · 2002
- Descendant · 2 generations on · 9 of its ownK030825 MPM-NetAerotel Medical Systems (1998), Ltd. · 2003
- Descendant · 2 generations on · 8 of its ownK041854 MPM SystemAerotel Medical Systems, Ltd. · 2004
- Descendant · 3 generations on · 7 of its ownK051544 Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc. · 2005
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K983717BP-Tel Trans-Telephonic Blood Pressure Measurement SystemAerotel Medical Systems (1998), Ltd. · 1999 · cites it directly11descendants
- K021447Tele-Cliniq Data Transmission System Blood Pressure Measurement SystemAerotel Medical Systems (1998), Ltd. · 2002 · 2 generations on10descendants
- K030825MPM-NetAerotel Medical Systems (1998), Ltd. · 2003 · 2 generations on9descendants
- K041854MPM SystemAerotel Medical Systems, Ltd. · 2004 · 2 generations on8descendants
- K051544Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc. · 2005 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950004 | Heartview (TM) 12-Lead Electrocardiograph Recorder/Transmitter | Aerotel, Ltd. | 1995 | — |
| +1 | 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 | — |
| +2 | K030825 | MPM-Net | Aerotel Medical Systems (1998), Ltd. | 2003 | — |
| +2 | K041854 | MPM System | Aerotel Medical Systems, Ltd. | 2004 | — |
| +3 | K051544 | Vitalcaregiving System | Advanced Monitoring Caregiving, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 163 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?
- Of its descendants, K983717 (Aerotel Medical Systems (1998), Ltd., 1999) has gone furthest, with 11 descendants of its own.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
https://510kreport.com/device/K950004 · printed Nov 4, 2026
Cite this page
510(k) Report. “K950004: Heartview (TM) 12-Lead Electrocardiograph Recorder/Transmitter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950004
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026