510(k) · Cleared
ClearedNX System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Telecare, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Aug 19, 2003 after a 209-day review. The FDA summary names its predicate without a number. 35 later devices descend from it.
- Decided
- Aug 19, 2003
- Review
- 209 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 0
35 later devices descend from it, 1 citing it directly.
- This deviceK030222 NX SystemAmerican Telecare, Inc. · 2003
- Descendant · cites it directly · 34 of its ownK041308 Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004
- Descendant · 2 generations on · 25 of its ownK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- Descendant · 3 generations on · 12 of its ownK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- Descendant · 3 generations on · 12 of its ownK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
- Descendant · 3 generations on · 11 of its ownK101178 Modification to Intel Health Guide PHS6000Intel Corp. · 2010
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K041308Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004 · cites it directly34descendants
- K080798Intel Health Guide, Model: PHS6000Intel Corp. · 2008 · 2 generations on25descendants
- K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009 · 3 generations on12descendants
- K083115Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008 · 3 generations on12descendants
- K101178Modification to Intel Health Guide PHS6000Intel Corp. · 2010 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030222 | NX System | American Telecare, Inc. | 2003 | — |
| +1 | K041308 | Remotenurse Patient Monitoring System | Webvmc, LLC | 2004 | — |
| +2 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| +3 | K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2009 | — |
| +3 | K083115 | Modification to Intel Health Guide, Model PHS6000 | Intel Corp. | 2008 | — |
| +3 | K101178 | Modification to Intel Health Guide PHS6000 | Intel Corp. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | — | American TeleCare’s Aviva 200 System Named without a submission number |
What descends from it? (35)
See all 351 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041308 | Remotenurse Patient Monitoring System | 2004 | 34 |
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?
- Of its descendants, K041308 (Webvmc, LLC, 2004) has gone furthest, with 34 descendants of its own.
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 NX System is intended to be used as a monitoring device when time-critical care is not required. The peripheral devices compatible with the NX System are blood pressure, pulse, weight, oxygen saturation, glucose and PTANR. The NX System enables the home-bound patient to retrieve data taken by the peripheral devices and forward them to an off-site central location for access by a health care professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030222 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030222: NX System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030222
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