510(k) · Cleared
ClearedDLM112 Daylink Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rtx Healthcare A/S · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Sep 29, 2006 as substantially equivalent to K041816 (Rtx Healthcare A/S, 2004) and 2 other predicates after a 52-day review. Its family tree reaches back 8 generations to 1987. 8 later devices descend from it.
- Decided
- Sep 29, 2006
- Review
- 52 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K864318 (1987). 25 ancestors in all, the oldest K790130 (1979). 8 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 7 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 6 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 5 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 4 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 3 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 2 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 1 generation backK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
- This deviceK062304 DLM112 Daylink MonitorRtx Healthcare A/S · 2006
- Descendant · cites it directly · 3 of its ownK090801 Electronic House CallExpress MD Solutions, LLC · 2009
- Descendant · cites it directly · 3 of its ownK071953 RTX3370Rtx Healthcare A/S · 2007
- Descendant · 2 generations on · 2 of its ownK090886 RTX 3371Tunstall Healthcare · 2009
- Descendant · 2 generations on · 1 of its ownK102063 Health-E-Connect SystemAlr Technologies · 2011
- Descendant · 3 generations on · 1 of its ownK103796 Telemedcare Health MonitorTelemedcare Pty, Ltd. · 2011
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K090801Electronic House CallExpress MD Solutions, LLC · 2009 · cites it directly3descendants
- K071953RTX3370Rtx Healthcare A/S · 2007 · cites it directly3descendants
- K090886RTX 3371Tunstall Healthcare · 2009 · 2 generations on2descendants
- K102063Health-E-Connect SystemAlr Technologies · 2011 · 2 generations on1descendant
- K103796Telemedcare Health MonitorTelemedcare Pty, Ltd. · 2011 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −7 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −6 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −5 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −4 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −3 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −2 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −1 | K042273 | Modification to Health Buddy with Device Connectivity | Health Hero Network, Inc. | 2004 | — |
| 0 (this device) | K062304 | DLM112 Daylink Monitor | Rtx Healthcare A/S | 2006 | — |
| +1 | K090801 | Electronic House Call | Express MD Solutions, LLC | 2009 | — |
| +1 | K071953 | RTX3370 | Rtx Healthcare A/S | 2007 | — |
| +2 | K090886 | RTX 3371 | Tunstall Healthcare | 2009 | — |
| +2 | K102063 | Health-E-Connect System | Alr Technologies | 2011 | — |
| +3 | K103796 | Telemedcare Health Monitor | Telemedcare Pty, Ltd. | 2011 | — |
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 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K041816 | RTX3320PSTN Wireless Telehealth GatewaySummary page 1…smitter And Receiver. Classification no: DRG Predicate Device: The DLM1 12 device is substantially equivalent to the following predicate devices: 510(k) number: K041816 Device name: RTX3320 Wireless Telehealth Gateway Applicant: RTX Healthcare 510(k) number: K023749 Device… | 2004 |
| * | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B)Summary page 1…llowing predicate devices: 510(k) number: K041816 Device name: RTX3320 Wireless Telehealth Gateway Applicant: RTX Healthcare 510(k) number: K023749 Device name: M3810A Philips Telemonitoring System with M3812B TeleStation. Applicant: Philips Medical Systems.… | 2002 |
| * | K042273 | Modification to Health Buddy with Device ConnectivitySummary page 1…mber: K023749 Device name: M3810A Philips Telemonitoring System with M3812B TeleStation. Applicant: Philips Medical Systems. 510(k) number: K042273 Device name: Health Buddy with Device Connectivity. Applicant: Health Hero Network Submission Device Descripti… | 2004 |
What descends from it? (8)
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 19 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 25 ancestors have a recall of any class.
- Of its descendants, K090801 (Express MD Solutions, LLC, 2009) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K041816.
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 Daylink 112 Monitor ("DLM1 12") is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable health care providers to receive historical patient information. It is intended to be used in combination with a variety of external devices. The DLM1 12 serves as the remote communication link between compatible external devices, and the compatible healthcare facility at another…
Read the full statement (136 words)
The Daylink 112 Monitor ("DLM1 12") is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable health care providers to receive historical patient information. It is intended to be used in combination with a variety of external devices. The DLM1 12 serves as the remote communication link between compatible external devices, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management center or with the healthcare/wellness provider or other out of hospital caregivers. The purpose is to collect and transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line.
The DLM1 12 Monitor does not measure, interpret or make any decisions on the vital data that it conveys.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062304 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062304: DLM112 Daylink Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062304
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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