510(k) · Cleared
ClearedModification of: Physiological 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 Co. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Dec 20, 1999 as substantially equivalent to K790130 (Acme Medical Scale Co., 1979) and 2 other predicates after an 89-day review. Its family tree reaches back 3 generations to 1987. 103 later devices descend from it.
- Decided
- Dec 20, 1999
- Review
- 89 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K864318 (1987). 10 ancestors in all, the oldest K790130 (1979). 103 later devices descend from it, 4 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 deviceK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- Descendant · cites it directly · 98 of its ownK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- Descendant · cites it directly · 90 of its ownK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- Descendant · cites it directly · 86 of its ownK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- Descendant · 2 generations on · 59 of its ownK041816 RTX3320PSTN Wireless Telehealth GatewayRtx Healthcare A/S · 2004
- Descendant · 2 generations on · 45 of its ownK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
Showing 5 of 103 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 103 · See all- K023749The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B)Philips Medical Systems · 2002 · cites it directly98descendants
- K031840Carematix Wellness SystemCarematix, Inc. · 2003 · cites it directly90descendants
- K040966Modification to Carematix Wellness SystemCarematix, Inc. · 2004 · cites it directly86descendants
- K041816RTX3320PSTN Wireless Telehealth GatewayRtx Healthcare A/S · 2004 · 2 generations on59descendants
- K050929The Hermes SystemPalaistra Systems, Inc. · 2005 · 2 generations on45descendants
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) | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| +1 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| +1 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| +1 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| +2 | K041816 | RTX3320PSTN Wireless Telehealth Gateway | Rtx Healthcare A/S | 2004 | — |
| +2 | K050929 | The Hermes System | Palaistra Systems, Inc. | 2005 | — |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 11 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 14 | 0 |
| 2010 | 10 | 0 |
| 2011 | 10 | 0 |
| 2012 | 6 | 0 |
| 2013 | 13 | 0 |
| 2014 | 6 | 0 |
| 2015 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 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 DRG? 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 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 407 K93 17… | 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 407 K93 17 HP CONFIDENTIAL Hewlett Packard Company M… | 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 407 K93 17 HP CONFIDENTIAL Hewlett Packard Company Model 3810A 510(k) Notification B. Device Description The H… | 1996 |
What descends from it? (103)
See all 1034 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 12 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K023749 (Philips Medical Systems, 2002) has gone furthest, with 98 descendants of its own.
- 1 other device also cites its predicate K790130.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
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…
Read the full statement (125 words)
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 may be used for the management of congestive heart failure, hypertension, ischemic heart disease, weight management, cardiovascular risk management, post cardiovascular surgery, post myocardial infarction and other post cardiac events. 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/K993169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993169: Modification of: Physiological Signal Transmitter and Receiver, Model 3810A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993169
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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