510(k) · Cleared
ClearedHS Amica
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
H.S Hospital Service S.P.A · NEY System, Ablation, Microwave And Accessories
Cleared on Sep 29, 2009 as substantially equivalent to K053535 (Valleylab, 2006) and 2 other predicates after a 340-day review. Its family tree reaches back 5 generations to 1986. 4 later devices descend from it.
- Decided
- Sep 29, 2009
- Review
- 340 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K861904 (1986). 27 ancestors in all, the oldest K790187 (1979). 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
- 4 generations backK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
- 3 generations backK023311 Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 2 generations backK032047 Tri-Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 1 generation backK032702 Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003
- This deviceK083157 HS AmicaH.S Hospital Service S.P.A · 2009
- Descendant · cites it directly · 2 of its ownK150112 HS Amica Devices FamilyH.S Hospital Service S.P.A · 2015
- Descendant · 2 generations on · 1 of its ownK182605 HS AMICA devices familyH.S Hospital Service S.P.A · 2019
- Descendant · 3 generations on · 0 of its ownK232072 Amica-Gen Agn-H-1.3, Amica-Gen Agn 3.3, Amica-Probe 17G & 18GH.S Hospital Service S.P.A · 2024
- Descendant · cites it directly · 0 of its ownK223272 SurBlate Ablation SystemMima-Pro Scientific, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K150112HS Amica Devices FamilyH.S Hospital Service S.P.A · 2015 · cites it directly2descendants
- K182605HS AMICA devices familyH.S Hospital Service S.P.A · 2019 · 2 generations on1descendant
- K232072Amica-Gen Agn-H-1.3, Amica-Gen Agn 3.3, Amica-Probe 17G & 18GH.S Hospital Service S.P.A · 2024 · 3 generations on0descendants
- K223272SurBlate Ablation SystemMima-Pro Scientific, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K861904 | HS-15M Microwave Surgery Equipment, Microtaze | Cooper Lasersonics, Inc. | 1986 | — |
| −4 | K011676 | Vivawave Microwave System | Vivant Medical, Inc. | 2002 | 1 |
| −3 | K023311 | Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −2 | K032047 | Tri-Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −1 | K032702 | Vivatip Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| 0 (this device) | K083157 | HS Amica | H.S Hospital Service S.P.A | 2009 | — |
| +1 | K150112 | HS Amica Devices Family | H.S Hospital Service S.P.A | 2015 | — |
| +2 | K182605 | HS AMICA devices family | H.S Hospital Service S.P.A | 2019 | — |
| +3 | K232072 | Amica-Gen Agn-H-1.3, Amica-Gen Agn 3.3, Amica-Probe 17G & 18G | H.S Hospital Service S.P.A | 2024 | — |
| +1 | K223272 | SurBlate Ablation System | Mima-Pro Scientific, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K053535 | Vivawave Microwave Ablation SystemSummary page 1…3. Predicate Device The HS AMICA is substantially equivalent in function and intended use 'to the following legally marketed device: VivaWave Microwave Ablation System (K053535) and VivaTip Microwave Ablation Probe (K032702). The HS AMICA pump is equivalent to that of Cool- Tip RF Ablation System (K042216… | 2006 |
| * | K032702 | Vivatip Microwave Ablation ProbeSummary page 1…lly equivalent in function and intended use 'to the following legally marketed device: VivaWave Microwave Ablation System (K053535) and VivaTip Microwave Ablation Probe (K032702). The HS AMICA pump is equivalent to that of Cool- Tip RF Ablation System (K042216). Though operating at different microwave freq… | 2003 |
| * | K042216 | Cool-Tip RF Ablation SystemSummary page 1…ce: VivaWave Microwave Ablation System (K053535) and VivaTip Microwave Ablation Probe (K032702). The HS AMICA pump is equivalent to that of Cool- Tip RF Ablation System (K042216). Though operating at different microwave frequencies (915 MHz for Vivawave and 2450 MHz for HS AMICA, respectively), both system… | 2004 |
What descends from it? (4)
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 23 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 5 of the 27 ancestors have a recall of any class.
- Of its descendants, K150112 (H.S Hospital Service S.P.A, 2015) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K053535.
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. 2009, 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?
HS AMICA is intended for coagulation (thermoablation) of soft tissues. Not for use in cardiac procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083157: HS Amica.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083157
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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