510(k) · Cleared
ClearedCaretaker Remote Display App and Caretaker Software Library
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caretaker Medical, LLC · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Oct 3, 2018 as substantially equivalent to K150992 (Vios Medical, Inc., 2015) and 1 other predicate after a 149-day review. Its family tree reaches back 12 generations to 1997. 1 later device descends from it.
- Decided
- Oct 3, 2018
- Review
- 149 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K962603 (1997). 62 ancestors in all, the oldest K872291 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 8 generations between
- 3 generations backK133586 Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013
- 2 generations backK143751 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- 1 generation backK150992 Vios Monitoring SystemVios Medical, Inc. · 2015
- This deviceK181196 Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC · 2018
- Descendant · cites it directly · 0 of its ownK211588 Caretaker Platform, VitalStream Platform, CT5Caretaker Medical · 2021
Show all 12 generations
- Root · 12 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 11 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 10 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 9 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 8 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 7 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 6 generations backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- 5 generations backK033378 Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004 · Recalled
- 4 generations backK122036 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
- 3 generations backK133586 Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013
- 2 generations backK143751 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
- 1 generation backK150992 Vios Monitoring SystemVios Medical, Inc. · 2015
- This deviceK181196 Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC · 2018
Most influential descendants
Showing 1 of 1 · See all- K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −11 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −10 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −9 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −8 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −7 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −6 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| −5 | K033378 | Vital Signs Monitor, Propaq LT | Welch Allyn Protocol, Inc. | 2004 | 3 |
| −4 | K122036 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | 2 |
| −3 | K133586 | Visi Mobile Monitioring System | Sotera Wireless, Inc. | 2013 | — |
| −2 | K143751 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | — |
| −1 | K150992 | Vios Monitoring System | Vios Medical, Inc. | 2015 | — |
| 0 (this device) | K181196 | Caretaker Remote Display App and Caretaker Software Library | Caretaker Medical, LLC | 2018 | — |
| +1 | K211588 | Caretaker Platform, VitalStream Platform, CT5 | Caretaker Medical | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (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 |
|---|---|---|---|
| * | K150992 | Vios Monitoring SystemSummary page 4…DRG - Transmitters And Receivers, Physiological Signal, Radiofrequency Device Class: II 5) Predicate Devices: VIOS Monitoring System, K150992 Airstrip ONE Web Client, K160862 6) Device Description: CareTaker Medical's App (“Care… | 2015 |
| * | K160862 | AirStrip RPMSummary page 4…Radiofrequency Device Class: II 5) Predicate Devices: VIOS Monitoring System, K150992 Airstrip ONE Web Client, K160862 6) Device Description: CareTaker Medical's App (“CareTaker Remote Display App”) is a software App that runs o… | 2016 |
| † | K163255 | CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211588 | Caretaker Platform, VitalStream Platform, CT5 | 2021 | 0 |
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 21 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 11 of the 62 ancestors have a recall of any class.
- Of its descendants, K211588 (Caretaker Medical, 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K150992.
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. 2018, this device’s year, is highlighted.
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 Caretaker Remote Display App and Caretaker Software Library are indicated for use when remote display and/or forwarding of securely transmitted wireless data from the Caretaker Physiological Monitor device (K163255) is required. The Remote Display App and the Software Library provides bi-directional data transfer capabilities with the Caretaker Physiological Monitor device (K163255). To facilitate communications between the Caretaker Physiological…
Read the full statement (174 words)
The Caretaker Remote Display App and Caretaker Software Library are indicated for use when remote display and/or forwarding of securely transmitted wireless data from the Caretaker Physiological Monitor device (K163255) is required. The Remote Display App and the Software Library provides bi-directional data transfer capabilities with the Caretaker Physiological Monitor device (K163255). To facilitate communications between the Caretaker Physiological Monitor device and other FDA Cleared patient monitors and Remote Data Displays (RDDS), the Caretaker Software Library provides a well-defined interface for 3rd party data integrations.
In addition to providing data display and forwarding, the Remote Display App can operate as an MDDS for 3rd party wireless medical devices. The alerts in the subject device are only to be used for historical review and are not intended for time-critical intervention.
The Software Library is intended only for use by licensed partners of the company, and the Caretaker Remote Display App is intended for use by clinicians or other properly trained medical personnel. Both the Remote Display App and Software Library are for prescriptive use only.
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/K181196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181196: Caretaker Remote Display App and Caretaker Software Library.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181196
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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