510(k) · Cleared
ClearedMagellan Ratio Dispenser Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Perfusion Systems · FMF Syringe, Piston
Cleared on Sep 29, 2004 as substantially equivalent to K020147 (Medtronic Perfusion Systems, 2002) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Sep 29, 2004
- Review
- 84 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K883338 (1988). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK883338 Surgical Sealant ApplicatorMicromedics, Inc. · 1988 · Recalled
- 1 generation backK020147 Magellan Ratio Dispenser Kit/Magellan Spray Tip/Magellan Cannula TipMedtronic Perfusion Systems · 2002
- This deviceK041830 Magellan Ratio Dispenser KitMedtronic Perfusion Systems · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883338 | Surgical Sealant Applicator | Micromedics, Inc. | 1988 | 2 |
| −1 | K020147 | Magellan Ratio Dispenser Kit/Magellan Spray Tip/Magellan Cannula Tip | Medtronic Perfusion Systems | 2002 | — |
| 0 (this device) | K041830 | Magellan Ratio Dispenser Kit | Medtronic Perfusion Systems | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K020147 | Magellan Ratio Dispenser Kit/Magellan Spray Tip/Magellan Cannula TipSummary page 1…redicate Device: 1) Magellan Ratio Dispenser Kit, Medtronic, Inc K020147 - 04/03/2002 2) Harvest Technologies Dual Liquid Applicator,… | 2002 |
| * | K020252 | Smartjet Grafting Liquid Applicator, Models SK/S & LK/2Summary page 1…2) Harvest Technologies Dual Liquid Applicator, Harvest Technologies K020252 - 04/05/2002 Device Description: The Magellan Ratio Dispenser Kit consists of the… | 2002 |
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 16 years and passes through 2 companies; a new generation was cleared every 13.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The Magellan Ratio Dispenser Kit is intended for the application of fluids, as deemed necessary by the surgeon's determination of the clinical use requirements, to facilitate the preparation of soft tissue prior to repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041830 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041830: Magellan Ratio Dispenser Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041830
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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