510(k) · Cleared
ClearedHS AMICA devices family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
H.S Hospital Service S.P.A · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 28, 2019 as substantially equivalent to K150112 (H.S Hospital Service S.P.A, 2015) after a 402-day review. Its family tree reaches back 7 generations to 1987. 1 later device descends from it.
- Decided
- Oct 28, 2019
- Review
- 402 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K870028 (1987). 30 ancestors in all, the oldest K790187 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 6 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 5 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 4 generations backK021329 Rita SystemRita Medical Systems · 2002
- 3 generations backK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- 2 generations backK053290 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- 1 generation backK150112 HS Amica Devices FamilyH.S Hospital Service S.P.A · 2015
- This deviceK182605 HS AMICA devices familyH.S Hospital Service S.P.A · 2019
- Descendant · cites it directly · 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
Most influential descendants
Showing 1 of 1 · See all- K232072Amica-Gen Agn-H-1.3, Amica-Gen Agn 3.3, Amica-Probe 17G & 18GH.S Hospital Service S.P.A · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −6 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −5 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −4 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| −3 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| −2 | K053290 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| −1 | K150112 | HS Amica Devices Family | H.S Hospital Service S.P.A | 2015 | — |
| 0 (this device) | K182605 | HS AMICA devices family | H.S Hospital Service S.P.A | 2019 | — |
| +1 | K232072 | Amica-Gen Agn-H-1.3, Amica-Gen Agn 3.3, Amica-Probe 17G & 18G | H.S Hospital Service S.P.A | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1986 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 5 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K150112 | HS Amica Devices FamilySummary page 5…A devices family Applicant Device name 510(k) Number H.S. HOSPITAL SERVICE S.P.A. HS AMICA devices family K150112 4. Device Description HS AMICA devices family is the advance version of the design of the legally marketed HS AMICA device… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232072 | Amica-Gen Agn-H-1.3, Amica-Gen Agn 3.3, Amica-Probe 17G & 18G | 2024 | 0 |
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 32 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 5 of the 30 ancestors have a recall of any class.
- Of its descendants, K232072 (H.S Hospital Service S.P.A, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
Coagulation (thermo-ablation) of soft tissue. Not 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/K182605 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182605: HS AMICA devices family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182605
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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