510(k) · Cleared
ClearedNetlink/Netscan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rozinn Electronics, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Apr 5, 2002 as substantially equivalent to K982090 (Paceart, Inc., 1999) after a 73-day review. Its family tree reaches back 3 generations to 1994. 4 later devices descend from it.
- Decided
- Apr 5, 2002
- Review
- 73 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930806 (1994). 6 ancestors in all, the oldest K872781 (1987). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 2 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- 1 generation backK982090 Paceart Home Trak Plus Easi Event Recorder SystemPaceart, Inc. · 1999
- This deviceK020213 Netlink/NetscanRozinn Electronics, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK042002 Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc. · 2004
- Descendant · 2 generations on · 2 of its ownK193177 CER-SCardiocalm · 2020
- Descendant · 3 generations on · 1 of its ownK213861 CER-SCardiocalm Srl · 2022
- Descendant · 4 generations on · 0 of its ownK243312 CER-SCardiocalm Srl · 2025
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −2 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| −1 | K982090 | Paceart Home Trak Plus Easi Event Recorder System | Paceart, Inc. | 1999 | — |
| 0 (this device) | K020213 | Netlink/Netscan | Rozinn Electronics, Inc. | 2002 | — |
| +1 | K042002 | Synescope, Easyscope, Synecom, Holterreader | Ela Medical, Inc. | 2004 | — |
| +2 | K193177 | CER-S | Cardiocalm | 2020 | — |
| +3 | K213861 | CER-S | Cardiocalm Srl | 2022 | — |
| +4 | K243312 | CER-S | Cardiocalm Srl | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 DXH? 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 DXH device
- #1 K243438 MEMO Patch M (MPT-E08R-UNC01)score 12.9 · 9 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 |
|---|---|---|---|
| * | K982090 | Paceart Home Trak Plus Easi Event Recorder SystemSummary page 1…Electrocardiograph telephone (per 21 CFR 870.2920) Substantial Equivalence claimed to legally marketed device: PaceArt HomeTrak Plus EASI Event Recorder System- £10(k) K982090 Description of Device: Netlink/Netscan is an accessory to Northeast Monitoring’s Holter for Windows Holter Scanner (K930564) th… | 1999 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042002 | Synescope, Easyscope, Synecom, Holterreader | 2004 | 3 |
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 8 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K042002 (Ela Medical, Inc., 2004) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K982090.
How does its category compare?
All DXH devicesDXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXH
322in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXH
27in 2025
MAUDE reports naming product code DXH, 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 | 3 | 202 | 0 | 0 |
| 2008 | 7 | 41 | 4 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 3 | 206 | 0 | 1 |
| 2014 | 6 | 186 | 0 | 1 |
| 2015 | 4 | 142 | 1 | 0 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 5 | 150 | 0 | 4 |
| 2018 | 4 | 294 | 0 | 0 |
| 2019 | 6 | 177 | 0 | 0 |
| 2020 | 5 | 141 | 0 | 5 |
| 2021 | 3 | 107 | 0 | 2 |
| 2022 | 4 | 150 | 0 | 6 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 4 | 322 | 0 | 27 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Netlink/Netscan is a transmission software which will transmit ECG, ambulatory blood pressure, EKG, spirometry, and any other data files from a remote site to a central station for analysis using a modem, cable modera, ISDN line, T1 lines, DSL, Internet or Intranet and send the analyzed data back to the remote site from the central site using the same transmission media.
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/K020213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020213: Netlink/Netscan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020213
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