510(k) · Cleared
ClearedSIR-Spheres Microspheres Activity Calculator (SMAC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirtex Medical US Holdings, Inc. · KPS System, Tomography, Computed, Emission
Cleared on Oct 23, 2020 as substantially equivalent to K181468 (Hermes Medical Solutions AB, 2018) after a 63-day review. Its family tree reaches back 15 generations to 2001.
- Decided
- Oct 23, 2020
- Review
- 63 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K010641 (2001). 30 ancestors in all, the oldest K914350 (1991). No later device cites it as a predicate yet.
- Root · 15 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 11 generations between
- 3 generations backK163394 Hybrid3DHermes Medical Solutions AB · 2017
- 2 generations backK171719 Hybrid3DHermes Medical Solutions AB · 2017
- 1 generation backK181468 Hybrid3DHermes Medical Solutions AB · 2018
- This deviceK202392 SIR-Spheres Microspheres Activity Calculator (SMAC)Sirtex Medical US Holdings, Inc. · 2020
Show all 15 generations
- Root · 15 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 14 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 13 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 12 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 11 generations backK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- 10 generations backK061545 Scenium 1.1Siemens Molecular Imaging, Ltd. · 2006
- 9 generations backK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
- 8 generations backK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
- 7 generations backK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- 6 generations backK140269 Hermes Medical Imaging Suite V5.4Hermes Medical Solutions AB · 2014
- 5 generations backK142631 Hermes Medical Imaging Suite v5.5Hermes Medical Solutions AB · 2014
- 4 generations backK153056 Hermes Medical Imaging Suite v5.6Hermes Medical Solutions AB · 2016
- 3 generations backK163394 Hybrid3DHermes Medical Solutions AB · 2017
- 2 generations backK171719 Hybrid3DHermes Medical Solutions AB · 2017
- 1 generation backK181468 Hybrid3DHermes Medical Solutions AB · 2018
- This deviceK202392 SIR-Spheres Microspheres Activity Calculator (SMAC)Sirtex Medical US Holdings, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −14 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −13 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −12 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −11 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| −10 | K061545 | Scenium 1.1 | Siemens Molecular Imaging, Ltd. | 2006 | — |
| −9 | K121074 | Scenium 2.0 | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −8 | K123528 | Scenium | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −7 | K130884 | Xeleris 3.1 Processing and Review Workstation | Ge Medical Systems F.I. Haifa | 2013 | — |
| −6 | K140269 | Hermes Medical Imaging Suite V5.4 | Hermes Medical Solutions AB | 2014 | — |
| −5 | K142631 | Hermes Medical Imaging Suite v5.5 | Hermes Medical Solutions AB | 2014 | — |
| −4 | K153056 | Hermes Medical Imaging Suite v5.6 | Hermes Medical Solutions AB | 2016 | — |
| −3 | K163394 | Hybrid3D | Hermes Medical Solutions AB | 2017 | — |
| −2 | K171719 | Hybrid3D | Hermes Medical Solutions AB | 2017 | — |
| −1 | K181468 | Hybrid3D | Hermes Medical Solutions AB | 2018 | — |
| 0 (this device) | K202392 | SIR-Spheres Microspheres Activity Calculator (SMAC) | Sirtex Medical US Holdings, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 KPS? 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 KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 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 |
|---|---|---|---|
| * | K181468 | Hybrid3DSummary page 4…e) The following legally marketed device has been used for comparison. Proprietary/Trade Name Trade Name: HERMES Hybrid3D v3.0 SIRT (K181468) E. Description of the device that is subject of this premarket notification: The SIR‐Spheres Microspheres Activity Calculator (… | 2018 |
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 19 years and passes through 8 companies; a new generation was cleared every 12 months on median.
- 7 of the 30 ancestors have a recall of any class.
- 2 other devices also cite its predicate K181468.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, 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 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
The SIR-Spheres® Microspheres Activity Calculator (SMAC) is intended as a tool to assist with developing personalized dose activity calculations, based on relevant patient data, for patients undergoing selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres. Using the BSA formula, the SMAC automatically performs calculations that are typically done manually by a physicist and/or licensed healthcare practitioner. The algorithms used have been established and documented in scientific literature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202392: SIR-Spheres Microspheres Activity Calculator (SMAC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202392
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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