510(k) · Cleared
ClearedAlio Medical Remote Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Graftworx, Inc. Dba Alio · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Mar 24, 2022 as substantially equivalent to K152139 (Vitalconnect, Inc., 2015) after a 324-day review. Its family tree reaches back 9 generations to 1997. 3 later devices descend from it.
- Decided
- Mar 24, 2022
- Review
- 324 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K962603 (1997). 26 ancestors in all, the oldest K891104 (1989). 3 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations between
- 3 generations backK113054 EquivitalHidalgo Limited · 2012
- 2 generations backK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- 1 generation backK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- This deviceK211365 Alio Medical Remote Monitoring SystemGraftworx, Inc. Dba Alio · 2022
- Descendant · cites it directly · 0 of its ownK252984 Perin Health System (PHD80060-2)Perin Health Devices, LLC · 2026
- Descendant · cites it directly · 0 of its ownK252440 EasyTeleMed (2.0.2)Ingeniars S.R.L. · 2025
- Descendant · cites it directly · 0 of its ownK223073 AlioAlio, Inc. · 2023
Show all 9 generations
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 8 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 7 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 6 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 5 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 4 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 3 generations backK113054 EquivitalHidalgo Limited · 2012
- 2 generations backK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- 1 generation backK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- This deviceK211365 Alio Medical Remote Monitoring SystemGraftworx, Inc. Dba Alio · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −8 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −7 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −6 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −5 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −4 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −3 | K113054 | Equivital | Hidalgo Limited | 2012 | — |
| −2 | K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software… | Vitalconnect, Inc. | 2014 | — |
| −1 | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | Vitalconnect, Inc. | 2015 | — |
| 0 (this device) | K211365 | Alio Medical Remote Monitoring System | Graftworx, Inc. Dba Alio | 2022 | — |
| +1 | K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | 2026 | — |
| +1 | K252440 | EasyTeleMed (2.0.2) | Ingeniars S.R.L. | 2025 | — |
| +1 | K223073 | Alio | Alio, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatchSummary page 4…ct Code DRG, DQD Regulatory Class II 3. Predicate Device Proprietary Name Vital Connect Platform Premarket Notification K152139 Classification Name Radiofrequency physiological signal transmitter and receiver Regulation Number 21 CFR 870… | 2015 |
| † | K200776 | Eko CORE | 2020 |
| † | K190792 | BB-613WP | 2019 |
What descends from it? (3)
3 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 25 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 26 ancestors have a recall of any class.
- Of its descendants, K252984 (Perin Health Devices, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K152139.
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. 2022, 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 Alio Medical Remote Monitoring System is a wireless remote monitoring system intended for use by healthcare professionals to intermittently collect physiological data in home use settings. The data includes skin temperature, auscultation sound data and heart rate. Data is transmitted wirelessly from the SmartPatch wearable sensor to a web-based portal for the healthcare provider's (HCP) review. The Alio Medical RMS is intended for use on general care…
Read the full statement (142 words)
The Alio Medical Remote Monitoring System is a wireless remote monitoring system intended for use by healthcare professionals to intermittently collect physiological data in home use settings. The data includes skin temperature, auscultation sound data and heart rate. Data is transmitted wirelessly from the SmartPatch wearable sensor to a web-based portal for the healthcare provider's (HCP) review.
The Alio Medical RMS is intended for use on general care patients who are 18 years of age or older. The SmartPatch sensor is indicated to measure skin temperature and pulse rate where clinically indicated. The SmartPatch sensor is indicated to record and transmit auscultation sound data where clinically indicated.
The device is not intended for use in critical care or other high-acuity environments. The Alio Medical RMS is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211365: Alio Medical Remote Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211365
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