510(k) · Cleared
ClearedInfinity Telesmart Telemetry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical Systems, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Feb 16, 2007 as substantially equivalent to K024108 (Siemens Medical Solutions USA, Inc., 2002) and 1 other predicate after a 275-day review. Its family tree reaches back 9 generations to 1992. 26 later devices descend from it.
- Decided
- Feb 16, 2007
- Review
- 275 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K923682 (1992). 40 ancestors in all, the oldest K900598 (1990). 26 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK923682 Model M1032A Vuelink Interface Plug-in ModuleHewlett-Packard Co. · 1992
- 5 generations between
- 3 generations backK033807 Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol…Draeger Medical Systems, Inc. · 2004
- 2 generations backK043439 Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta…Draeger Medical Systems, Inc. · 2005
- 1 generation backK051658 Infinity AlphaDraeger Medical Systems, Inc. · 2005
- This deviceK061379 Infinity Telesmart Telemetry SystemDraeger Medical Systems, Inc. · 2007
- Descendant · cites it directly · 25 of its ownK130711 Infinity Centralstation with Infinity M300Draeger Medical Systems, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 23 of its ownK151860 Infinity CentralStation WideDraeger Medical Systems, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 19 of its ownK182543 Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap…Snap40, Ltd. · 2018
- Descendant · 4 generations on · 18 of its ownK190073 Wearable Device, Home Package in Carry Case with Homehub, Home…Current Health, Ltd. · 2019
- Descendant · 5 generations on · 16 of its ownK191272 Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019
Show all 9 generations
- Root · 9 generations backK923682 Model M1032A Vuelink Interface Plug-in ModuleHewlett-Packard Co. · 1992
- 8 generations backK970368 SC9000/SC9015 Medical Information Bus (Mis) Protocol ConverterSiemens Medical Solutions USA, Inc. · 1997
- 7 generations backK991661 Siemens Medical Information Bus (Mib) Protocol ConverterSiemens Medical Solutions USA, Inc. · 1999
- 6 generations backK012461 Siemens Infinity Mib II Duo Protocol ConverterSiemens Medical Solutions USA, Inc. · 2001
- 5 generations backK020277 Siemens Medical Infromation Bus (Mib II) Protocol ConverterSiemens Medical Solutions USA, Inc. · 2002
- 4 generations backK022766 Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol CoverterSiemens Medical Solutions USA, Inc. · 2002
- 3 generations backK033807 Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol…Draeger Medical Systems, Inc. · 2004
- 2 generations backK043439 Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta…Draeger Medical Systems, Inc. · 2005
- 1 generation backK051658 Infinity AlphaDraeger Medical Systems, Inc. · 2005
- This deviceK061379 Infinity Telesmart Telemetry SystemDraeger Medical Systems, Inc. · 2007
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K130711Infinity Centralstation with Infinity M300Draeger Medical Systems, Inc. · 2013 · cites it directly25descendants
- K151860Infinity CentralStation WideDraeger Medical Systems, Inc. · 2015 · 2 generations on23descendants
- K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd. · 2018 · 3 generations on19descendants
- K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd. · 2019 · 4 generations on18descendants
- K191272Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019 · 5 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K923682 | Model M1032A Vuelink Interface Plug-in Module | Hewlett-Packard Co. | 1992 | — |
| −8 | K970368 | SC9000/SC9015 Medical Information Bus (Mis) Protocol Converter | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −7 | K991661 | Siemens Medical Information Bus (Mib) Protocol Converter | Siemens Medical Solutions USA, Inc. | 1999 | — |
| −6 | K012461 | Siemens Infinity Mib II Duo Protocol Converter | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −5 | K020277 | Siemens Medical Infromation Bus (Mib II) Protocol Converter | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −4 | K022766 | Siemens Medical Information Bus (Mib/Mib II/Mib Duo) Protocol Coverter | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −3 | K033807 | Infinityedical Information Bus (Mib/Mib II and Mib Duo) Protocol Converter | Draeger Medical Systems, Inc. | 2004 | — |
| −2 | K043439 | Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista… | Draeger Medical Systems, Inc. | 2005 | — |
| −1 | K051658 | Infinity Alpha | Draeger Medical Systems, Inc. | 2005 | — |
| 0 (this device) | K061379 | Infinity Telesmart Telemetry System | Draeger Medical Systems, Inc. | 2007 | — |
| +1 | K130711 | Infinity Centralstation with Infinity M300 | Draeger Medical Systems, Inc. | 2013 | 2 |
| +2 | K151860 | Infinity CentralStation Wide | Draeger Medical Systems, Inc. | 2015 | 2 |
| +3 | K182543 | Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple… | Snap40, Ltd. | 2018 | — |
| +4 | K190073 | Wearable Device, Home Package in Carry Case with Homehub, Home Package in… | Current Health, Ltd. | 2019 | — |
| +5 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K024108 | Siemens Multi View Infinity Telemetry SystemSummary page 1…ogical Monitors Radiofrequency Physiological 74DRG II 21 CFR 870.2910 Signal Transmitter and Receiver 3. Predicate Device Identification: K024108 Infinity MultiView Workstation Telemetry K051658 Infinity Alpha 4. Device Description: The INFINIT… | 2002 |
| * | K051658 | Infinity AlphaSummary page 1…74DRG II 21 CFR 870.2910 Signal Transmitter and Receiver 3. Predicate Device Identification: K024108 Infinity MultiView Workstation Telemetry K051658 Infinity Alpha 4. Device Description: The INFINITY TeleSmart is a patient-worn transceiver (PWT) that is… | 2005 |
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130711 | Infinity Centralstation with Infinity M300 | 2013 | 25 |
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 15 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 40 ancestors has a recall.
- Of its descendants, K130711 (Draeger Medical Systems, Inc., 2013) has gone furthest, with 25 descendants of its own.
- 1 other device also cites its predicate K024108.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
https://510kreport.com/device/K061379 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061379: Infinity Telesmart Telemetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061379
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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