510(k) · Cleared
ClearedSubtlePET
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Subtle Medical, Inc. · KPS System, Tomography, Computed, Emission
Cleared on Sep 28, 2021 as substantially equivalent to K182336 (Subtle Medical, Inc., 2018) after a 96-day review. Its family tree reaches back 5 generations to 1992. 2 later devices descend from it.
- Decided
- Sep 28, 2021
- Review
- 96 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K922470 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 4 generations backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- 3 generations backK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- 2 generations backK063391 Sapheneia ClaritySapheneia Commercial Products AB · 2007
- 1 generation backK182336 SubtlePETSubtle Medical, Inc. · 2018
- This deviceK211964 SubtlePETSubtle Medical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK261305 Micsi-PetMicrostructure Imaging, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK254013 SubtleHD-PET (1.x)Subtle Medical, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| −4 | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| −3 | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| −2 | K063391 | Sapheneia Clarity | Sapheneia Commercial Products AB | 2007 | — |
| −1 | K182336 | SubtlePET | Subtle Medical, Inc. | 2018 | — |
| 0 (this device) | K211964 | SubtlePET | Subtle Medical, Inc. | 2021 | — |
| +1 | K261305 | Micsi-Pet | Microstructure Imaging, Inc. | 2026 | — |
| +1 | K254013 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K182336 | SubtlePETSummary page 4…system Device Class: Class II Product Codes: KPS, LLZ 510(k) Number: K182336 510(k) Clearance Date: November 30, 2018… | 2018 |
What descends from it? (2)
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 29 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K261305 (Microstructure Imaging, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K182336.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
SubtlePET is an image processing software intended for use by radiologists and nuclear medicine physicians for transfer, storage, and noise reduction of fluorodeoxyglucose (FDG), amyloid, 18F-DOPA, 18F-DCFPyL, Ga-68 Dotatate, and Ga-68 PSMA radiotracer PET images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211964 · printed Nov 5, 2026
Cite this page
510(k) Report. “K211964: SubtlePET.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K211964
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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