510(k) · Cleared
ClearedFyrelink
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mpacs, LLC · LLZ System, Image Processing, Radiological
Cleared on Mar 10, 2003 as substantially equivalent to K980060 (Mpacs, LLC, 1998) and 2 other predicates after a 46-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Mar 10, 2003
- Review
- 46 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K950279 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950279 | TOMTECP90 | Tomtec Imaging Systems, Inc. | 1995 | — |
| −2 | K964803 | Univision Echocardiology System | Network Concepts, Inc. | 1997 | — |
| −1 | K980060 | Echolink | Mpacs, LLC | 1998 | — |
| 0 (this device) | K030242 | Fyrelink | Mpacs, LLC | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 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? (3)
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 |
|---|---|---|---|
| * | K980060 | EcholinkSummary page 2…-8- MPACS. LLC E. Equivalent Devices The equivalent legally marketed devices are the echoLINK system (5 10(k) Number K980060) manufactured by MPACS and the EnConcert system ( 5 1O(k) Number K954668) manufactured by Philips Medical Systems for routine ech… | 1998 |
| * | K954668 | HP Echo Image Management SystemSummary page 2…ivalent Devices The equivalent legally marketed devices are the echoLINK system (5 10(k) Number K980060) manufactured by MPACS and the EnConcert system ( 5 1O(k) Number K954668) manufactured by Philips Medical Systems for routine echocardiography and the TomTecPg0( 5 1O(k) Number K950279) manufactured by… | 1995 |
| * | K950279 | TOMTECP90Summary page 2…ctured by MPACS and the EnConcert system ( 5 1O(k) Number K954668) manufactured by Philips Medical Systems for routine echocardiography and the TomTecPg0( 5 1O(k) Number K950279) manufactured by TomTec Imaging Systems, Inc. for stress echocardiography. F. Device Description fyreLINK (formerly echoLINK) n… | 1995 |
| † | K964803 | Univision Echocardiology System | 1997 |
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 8 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 4 ancestors has a recall.
- 4 other devices also cite its predicate K980060.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
This device is intended for use by health care professionals trained in the field of echocardiography or medical ultrasound. It is to be used when there is a need to convert ultrasound video to a digital video format for subsequent review and archiving. This device is also intended for use in transferring ultrasound images over digital networks and/or digital communication lines.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030242 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030242: Fyrelink.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030242
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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