510(k) · Cleared
ClearedPhysiological Signal Transmitter and Receiver, Model 3810A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hewlett-Packard, Healthcare Solutions Group · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Oct 15, 1999 as substantially equivalent to K790130 (Acme Medical Scale Co., 1979) and 2 other predicates after an 81-day review. Its family tree reaches back 3 generations to 1987. 35 later devices descend from it.
- Decided
- Oct 15, 1999
- Review
- 81 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K864318 (1987). 10 ancestors in all, the oldest K790130 (1979). 35 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 2 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 1 generation backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- This deviceK992478 Physiological Signal Transmitter and Receiver, Model 3810AHewlett-Packard, Healthcare Solutions Group · 1999
- Descendant · cites it directly · 34 of its ownK041674 The M3810A Philips Telemonitoring System with M3814A SPO2 UnitPhilips Medical Systems · 2004 · Recalled
- Descendant · 2 generations on · 30 of its ownK063612 Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006
- Descendant · 3 generations on · 25 of its ownK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- Descendant · 4 generations on · 12 of its ownK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- Descendant · 4 generations on · 12 of its ownK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K041674The M3810A Philips Telemonitoring System with M3814A SPO2 UnitPhilips Medical Systems · 2004 · cites it directly34descendants
- K063612Modification to Health Buddy ApplianceHealth Hero Network, Inc. · 2006 · 2 generations on30descendants
- K080798Intel Health Guide, Model: PHS6000Intel Corp. · 2008 · 3 generations on25descendants
- K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009 · 4 generations on12descendants
- K083115Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008 · 4 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −2 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −1 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| 0 (this device) | K992478 | Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard, Healthcare Solutions Group | 1999 | — |
| +1 | K041674 | The M3810A Philips Telemonitoring System with M3814A SPO2 Unit | Philips Medical Systems | 2004 | 2 |
| +2 | K063612 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | 2006 | — |
| +3 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| +4 | K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2009 | — |
| +4 | K083115 | Modification to Intel Health Guide, Model PHS6000 | Intel Corp. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K790130 | Scale, Digital ChairSummary page 1…is substantially equivalent to the following predicate devices. Table 1 Predicate Devices Ref. Sponsor Predicate Device 510(k) Number # 1 | Acme Medical Digital Scale K790130 2 | Instromedix Lifesigns System K964408 3 | American Telecare Personal Telemedicine System K952882 402 HP CONFI… | 1979 |
| * | K964408 | Poseidon Cardiac Monitoring System (PCMS)Summary page 1…wing predicate devices. Table 1 Predicate Devices Ref. Sponsor Predicate Device 510(k) Number # 1 | Acme Medical Digital Scale K790130 2 | Instromedix Lifesigns System K964408 3 | American Telecare Personal Telemedicine System K952882 402 HP CONFIDENTIAL Hewlett Packard Company Model 381… | 1997 |
| * | K952882 | Personal Telemedicine SystemSummary page 1…onsor Predicate Device 510(k) Number # 1 | Acme Medical Digital Scale K790130 2 | Instromedix Lifesigns System K964408 3 | American Telecare Personal Telemedicine System K952882 402 HP CONFIDENTIAL Hewlett Packard Company Model 3810A 510(k) Notification B. Device Description The Hewlett-P… | 1996 |
What descends from it? (35)
See all 351 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041674 | The M3810A Philips Telemonitoring System with M3814A SPO2 Unit | 2004 | 34 |
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 12 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K041674 (Philips Medical Systems, 2004) has gone furthest, with 34 descendants of its own.
- 1 other device also cites its predicate K790130.
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 Model 3810A is indicated for patients at home, who are capable
and willing self-administrate this device, upon prescription of their healthcare provider, to
collect and transmit medical information such as weight, blood pressure (including pulse
rate) and non-diagnostic ECG rhythm strip to the healthcare provider at another location.
The patient takes these measurements, typically once per day, and the information is
transmitted automatically via normal telephone lines to the healthcare provider. The
device does not send any real-time alarms. Clinical judgement and experience are
required to check and interpret the information delivered.
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/K992478 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992478: Physiological Signal Transmitter and Receiver, Model 3810A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992478
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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