510(k) · Cleared
ClearedVitalware VMS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Televital, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on May 13, 2005 as substantially equivalent to K012171 (Visicu, Inc., 2001) and 3 other predicates after a 114-day review. Its family tree reaches back 12 generations to 1994.
- Decided
- May 13, 2005
- Review
- 114 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K941811 (1994). 68 ancestors in all, the oldest K872781 (1987). No later device cites it as a predicate yet.
- Root · 12 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 8 generations between
- 3 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 2 generations backK040357 M3290A Intellivue Information Center Software Release F.O and the…Philips Medical Systems, Inc. · 2004
- 1 generation backK041741 M3290A Intellivue Information Center Software Release F.0 and M4840A…Philips Medical Systems, Inc. · 2004 · Recalled
- This deviceK050128 Vitalware VMSTelevital, Inc. · 2005
Show all 12 generations
- Root · 12 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 11 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 10 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 9 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 8 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 7 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 6 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 5 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 4 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 3 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 2 generations backK040357 M3290A Intellivue Information Center Software Release F.O and the…Philips Medical Systems, Inc. · 2004
- 1 generation backK041741 M3290A Intellivue Information Center Software Release F.0 and M4840A…Philips Medical Systems, Inc. · 2004 · Recalled
- This deviceK050128 Vitalware VMSTelevital, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −11 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −10 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −9 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −8 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −7 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −6 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −5 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −4 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −3 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −2 | K040357 | M3290A Intellivue Information Center Software Release F.O and the M4840A… | Philips Medical Systems, Inc. | 2004 | — |
| −1 | K041741 | M3290A Intellivue Information Center Software Release F.0 and M4840A Philips… | Philips Medical Systems, Inc. | 2004 | 4 |
| 0 (this device) | K050128 | Vitalware VMS | Televital, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 13 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 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? (4)
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 |
|---|---|---|---|
| * | K012171 | Modification to: Argus System-Continuous Expert Care Network W/Smart AlramsSummary page 1…ver. Predicate Devices: Device Name 510(k) Number Argus System - Continuous Expert Care K012171 Network (modification of K001972 -10/27/00)… | 2001 |
| * | K001972 | Argus System-Continuous Expert Care NetworkSummary page 1…Argus System - Continuous Expert Care K012171 Network (modification of K001972 -10/27/00) MPT 24 and Vital View 24 K000276 Vit… | 2000 |
| * | K000276 | MPT 24 and Vital View 24Summary page 1…Network (modification of K001972 -10/27/00) MPT 24 and Vital View 24 K000276 VitalCom Network Monitoring System K041741 Description: The TeleVital VitalWare VMS is… | 2000 |
| * | K041741 | M3290A Intellivue Information Center Software Release F.0 and M4840A Philips Telemetry…Summary page 1…-10/27/00) MPT 24 and Vital View 24 K000276 VitalCom Network Monitoring System K041741 Description: The TeleVital VitalWare VMS is a software system utilized for the real-time collection, storage, transmission, sur… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- 5 of the 68 ancestors have a recall of any class.
- 2 other devices also cite its predicate K012171.
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 TeleVital VitalWare VMS is a vital sign monitoring and patient information software product intended to be used in conjunction with independent monitoring devices, and ancillary systems for the real-time collection, storage, and transmission to remote viewing sites.
The system is intended to be used in a hospital or clinic environment. Clinical judgment and experience are required to check and interpret the information delivered. VitalWare VMS is not intended to, and is not capable of controlling any of the medical devices it interfaces with.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050128 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050128: Vitalware VMS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050128
Report an extraction error
Are you the manufacturer?
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