510(k) · Cleared
ClearedRadionics Varilink 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radionics, A Division of Tyco Healthcare Group LP · IYE Accelerator, Linear, Medical
Cleared on Jan 16, 2003 as substantially equivalent to K993594 (Radionics, Inc., 1999) after an 87-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Jan 16, 2003
- Review
- 87 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970586 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK970586 Brainlab Micro Multi-Leaf CollimatorBrainlab Med. Computersysteme GmbH · 1997 · Recalled
- 2 generations backK982549 Radionics Mini Multi-Leaf Collimator, Model Radionics MMLCRadionics, Inc. · 1998
- 1 generation backK993594 Conformax MMLC VR1Radionics, Inc. · 1999
- This deviceK023519 Radionics Varilink 2Radionics, A Division of Tyco Healthcare Group LP · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970586 | Brainlab Micro Multi-Leaf Collimator | Brainlab Med. Computersysteme GmbH | 1997 | 1 |
| −2 | K982549 | Radionics Mini Multi-Leaf Collimator, Model Radionics MMLC | Radionics, Inc. | 1998 | — |
| −1 | K993594 | Conformax MMLC VR1 | Radionics, Inc. | 1999 | — |
| 0 (this device) | K023519 | Radionics Varilink 2 | Radionics, A Division of Tyco Healthcare Group LP | 2003 | — |
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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 |
|---|---|---|---|
| * | K993594 | Conformax MMLC VR1Summary page 1…is Medical charged-particle radiation therapy system. 3.0 The above device is substantial equivalent to the Radionics ConforMAX MMLCVRl was cleared via 5 1O(k), K993594, on December 15, 1999. 4.0 The device is an optional accessory 'for the Radionics Mini-Multileaf Collimator (MMLC), mounted… | 1999 |
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 6 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The VariLink 2 MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. The VariLink 2 MMLC can be used as a part of IMRT (Intensity Modulated Radiotherapy) or general conformal radiation treatment.
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/K023519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023519: Radionics Varilink 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023519
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