510(k) · Cleared
ClearedSwift System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emblation, Ltd. · NEY System, Ablation, Microwave And Accessories
Cleared on Oct 18, 2018 as substantially equivalent to K072870 (Foundry Newco X, Inc., 2008) and 2 other predicates after a 90-day review. Its family tree reaches back 10 generations to 1987. 3 later devices descend from it.
- Decided
- Oct 18, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K870028 (1987). 55 ancestors in all, the oldest K790187 (1979). 3 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 6 generations between
- 3 generations backK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- 2 generations backK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- 1 generation backK133821 Emprint Ablation SystemCovidien, LLC · 2014 · Recalled
- This deviceK181941 Swift SystemEmblation, Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK222388 swiftPro SystemEmblation, Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK240518 swiftPro™ SystemEmblation Limited · 2024
- Descendant · cites it directly · 0 of its ownK250718 swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited · 2025
Show all 10 generations
- Root · 10 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 9 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 8 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 7 generations backK021329 Rita SystemRita Medical Systems · 2002
- 6 generations backK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- 5 generations backK053290 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- 4 generations backK072687 Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008
- 3 generations backK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- 2 generations backK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- 1 generation backK133821 Emprint Ablation SystemCovidien, LLC · 2014 · Recalled
- This deviceK181941 Swift SystemEmblation, Ltd. · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −9 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −8 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −7 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| −6 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| −5 | K053290 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| −4 | K072687 | Valleylab Microwave Ablation Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2008 | — |
| −3 | K100744 | Certus 140 Microwave Ablation System and Accessories, Model Certus 140 | Neuwave Medical, Inc. | 2010 | — |
| −2 | K113237 | Certus 140 2.45GHZ Ablation System | Neuwave Medical, Inc. | 2012 | — |
| −1 | K133821 | Emprint Ablation System | Covidien, LLC | 2014 | 7 |
| 0 (this device) | K181941 | Swift System | Emblation, Ltd. | 2018 | — |
| +1 | K222388 | swiftPro System | Emblation, Ltd. | 2023 | — |
| +2 | K240518 | swiftPro™ System | Emblation Limited | 2024 | — |
| +1 | K250718 | swiftPro System (SWF-SPS); Swift System (SWF-SYS) | Emblation Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 2 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 NEY? 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 NEY device
- #1 K253771 Disposable Microwave Ablation Antenna…score 14.5 · 13 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 |
|---|---|---|---|
| * | K072870 | Microwave Tissue Coagulation System (MTCS)Summary page 4…II. PREDICATE DEVICE Trade Name: Microwave Tissue Coagulation System (MTCS) Common Name: Microwave ablation system and accessories 510K Number: K072870 Manufacturer: Foundry Newco X, Inc Trade Name: DTS G2 System Common Name: Microwave ablation system and… | 2008 |
| * | K082819 | Dermatologic Treatment System (DTS) G2Summary page 4…K072870 Manufacturer: Foundry Newco X, Inc Trade Name: DTS G2 System Common Name: Microwave ablation system and accessories 510K Number: K082819 Manufacturer: Miramar Lab, Inc Trade Name: Emprint Ablation System Common Name: Microwave ablation syste… | 2009 |
| * | K133821 | Emprint Ablation SystemSummary page 4…9 Manufacturer: Miramar Lab, Inc Trade Name: Emprint Ablation System Common Name: Microwave ablation system and accessories 510K Number: K133821 Manufacturer: Covidien LLC Reference Device Trade Name: Miradry System MD4000 Common Name: Microwave a… | 2014 |
| † | K180396 | miraDry System | 2018 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 31 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 8 of the 55 ancestors have a recall of any class.
- Of its descendants, K222388 (Emblation, Ltd., 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K072870.
How does its category compare?
All NEY devicesNEY System, Ablation, Microwave And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NEY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEY
94in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEY
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NEY
112in 2025
MAUDE reports naming product code NEY, 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 | 2 | — | 0 | 18 |
| 2008 | 3 | 145 | 0 | 15 |
| 2009 | 4 | 169 | 0 | 7 |
| 2010 | 3 | 219 | 0 | 28 |
| 2011 | 0 | — | 0 | 26 |
| 2012 | 3 | 81 | 0 | 9 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 1 | — | 0 | 27 |
| 2015 | 2 | — | 0 | 92 |
| 2016 | 3 | 30 | 0 | 176 |
| 2017 | 3 | 121 | 12 | 225 |
| 2018 | 3 | 90 | 3 | 102 |
| 2019 | 2 | — | 0 | 123 |
| 2020 | 7 | 178 | 0 | 128 |
| 2021 | 4 | 379 | 1 | 217 |
| 2022 | 1 | — | 1 | 142 |
| 2023 | 9 | 155 | 0 | 106 |
| 2024 | 7 | 94 | 0 | 141 |
| 2025 | 1 | — | 0 | 112 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Swift System is a surface based device intended for the coagulation of soft tissue during non-invasive procedures.
The Swift System is not indicated for use in cardiac procedures.
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/K181941 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181941: Swift System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181941
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