510(k) · Cleared
Recalled · Class II · 2020Jetstream Workspace
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adac Laboratories · KPS System, Tomography, Computed, Emission
Cleared on Nov 3, 2004 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 27 later devices descend from it. It has been recalled once.
- Decided
- Nov 3, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 1
- Predicates
- 0
27 later devices descend from it, 1 citing it directly.
- This deviceK042880 Jetstream WorkspaceAdac Laboratories · 2004
- Descendant · cites it directly · 26 of its ownK061029 Jetstream WorkspaceAdac Laboratories · 2006 · Recalled
- Descendant · 2 generations on · 12 of its ownK080961 NM Application SuitePhilips Nuclear Medicine, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 10 of its ownK072468 Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2007 · Recalled
- Descendant · 3 generations on · 9 of its ownK110507 Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011
- Descendant · 3 generations on · 9 of its ownK111336 EBW NM 2.0Philips Medical Systems (Cleveland), Inc. · 2011
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K061029Jetstream WorkspaceAdac Laboratories · 2006 · cites it directly26descendants
- K080961NM Application SuitePhilips Nuclear Medicine, Inc. · 2008 · 2 generations on12descendants
- K072468Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2007 · 2 generations on10descendants
- K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011 · 3 generations on9descendants
- K111336EBW NM 2.0Philips Medical Systems (Cleveland), Inc. · 2011 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042880 | Jetstream Workspace | Adac Laboratories | 2004 | — |
| +1 | K061029 | Jetstream Workspace | Adac Laboratories | 2006 | 1 |
| +2 | K080961 | NM Application Suite | Philips Nuclear Medicine, Inc. | 2008 | 1 |
| +2 | K072468 | Modification to D-Spect Cardiac Scanner System | Spectrum Dynamics, Ltd. | 2007 | 1 |
| +3 | K110507 | Cardiac Scanner and Processing System | Spectrum Dynamics (Israel), Ltd. | 2011 | — |
| +3 | K111336 | EBW NM 2.0 | Philips Medical Systems (Cleveland), Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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 18.7 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (27)
See all 271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061029 | Jetstream Workspace | 2006 | 26 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 19, 2020 | Class II | Z-0852-2021 | Device Design | A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061029 (Adac Laboratories, 2006) has gone furthest, with 26 descendants of its own.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K042880 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042880: Jetstream Workspace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042880
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026