510(k) · Cleared
ClearedxR IVD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tempus AI, Inc. · PZM Next Generation Sequencing Based Tumor Profiling Test
Cleared on Sep 19, 2025 as substantially equivalent to DEN170058 (Memorial Sloan-Kettering Cancer Center, 2017) after a 449-day review. Its family tree reaches back 1 generation to 2017.
- Decided
- Sep 19, 2025
- Review
- 449 days
- Class
- Class II
- Product code
- PZM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170058 (2017). No later device cites it as a predicate yet.
- Root · 1 generation backDEN170058 MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer…Memorial Sloan-Kettering Cancer Center · 2017
- This deviceK241868 xR IVDTempus AI, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170058 | MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a… | Memorial Sloan-Kettering Cancer Center | 2017 | — |
| 0 (this device) | K241868 | xR IVD | Tempus AI, Inc. | 2025 | — |
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 PZM? 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 PZM device
- #1 K260235 CellDx-Tissuescore 11.3 · 1 generation · 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 |
|---|---|---|---|
| * | DEN170058 | MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a…Summary page 5…ce: MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) Submission Number: DEN170058 Product Code: PZM A. Intended Use The Tempus xR IVD assay is a qualitative next generation s… | 2017 |
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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate DEN170058.
How does its category compare?
All PZM devicesPZM Next Generation Sequencing Based Tumor Profiling Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PZM
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PZM
Too few PZM 510(k)s in any year since 2007 to give a median.
Recalls per year · PZM
No recall names PZM since 2007.
Adverse event reports per year · PZM
No MAUDE report names PZM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Tempus xR IVD assay is a qualitative next generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for detection of rearrangements in two genes, using RNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens from patients with solid malignant neoplasms. Information provided by xR IVD is intended to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms. Results from xR IVD are not intended to be prescriptive or conclusive for labeled use of any specific therapeutic product.
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/K241868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241868: xR IVD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241868
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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