De Novo · Granted
GrantedMSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Memorial Sloan-Kettering Cancer Center · PZM Next Generation Sequencing Based Tumor Profiling Test
Granted on Nov 15, 2017 as a new device type through De Novo after a 51-day review. 6 later devices descend from it.
- Decided
- Nov 15, 2017
- Review
- 51 days
- Class
- Class II
- Product code
- PZM
- Recalls
- None
6 later devices descend from it, 5 citing it directly.
- This deviceDEN170058 MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer…Memorial Sloan-Kettering Cancer Center · 2017
- Descendant · cites it directly · 1 of its ownK192063 PGDx elio tissue completePersonal Genome Diagnostics · 2020
- Descendant · cites it directly · 0 of its ownK260235 CellDx-TissueDatar Cancer Genetics Private Limited · 2026
- Descendant · cites it directly · 0 of its ownK241868 xR IVDTempus AI, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK250003 GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)Geneseeq Technology, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK210017 ACTOnco, ACTOnco IVDAct Genomics · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K192063PGDx elio tissue completePersonal Genome Diagnostics · 2020 · cites it directly1descendant
- K260235CellDx-TissueDatar Cancer Genetics Private Limited · 2026 · cites it directly0descendants
- K241868xR IVDTempus AI, Inc. · 2025 · cites it directly0descendants
- K250003GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)Geneseeq Technology, Inc. · 2025 · 2 generations on0descendants
- K210017ACTOnco, ACTOnco IVDAct Genomics · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170058 | MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a… | Memorial Sloan-Kettering Cancer Center | 2017 | — |
| +1 | K192063 | PGDx elio tissue complete | Personal Genome Diagnostics | 2020 | — |
| +1 | K260235 | CellDx-Tissue | Datar Cancer Genetics Private Limited | 2026 | — |
| +1 | K241868 | xR IVD | Tempus AI, Inc. | 2025 | — |
| +2 | K250003 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) | Geneseeq Technology, Inc. | 2025 | — |
| +1 | K210017 | ACTOnco, ACTOnco IVD | Act Genomics | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (6)
5 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?
- Of its descendants, K192063 (Personal Genome Diagnostics, 2020) has gone furthest, with 1 descendant of its own.
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. 2017, 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 MSK-IMPACT assay is a qualitative in vitro diagnostic test that uses targeted next generation sequencing of formalin-fixed paraffin-embedded tumor tissue matched with normal specimens from patients with solid malignant neoplasms to detect tumor gene alterations in a broad multi gene panel. The test is intended to provide information on somatic mutations (point mutations and small insertions and deletions) and microsatellite instability for use by…
Read the full statement (100 words)
The MSK-IMPACT assay is a qualitative in vitro diagnostic test that uses targeted next generation sequencing of formalin-fixed paraffin-embedded tumor tissue matched with normal specimens from patients with solid malignant neoplasms to detect tumor gene alterations in a broad multi gene panel. The test is intended to provide information on somatic mutations (point mutations and small insertions and deletions) and microsatellite instability for use by qualified health care professionals in accordance with professional guidelines, and is not conclusive or prescriptive for labeled use of any specific therapeutic product. MSK-IMPACT is a single-site assay performed at Memorial Sloan Kettering Cancer Center.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170058 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170058: MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170058
Report an extraction error
Are you the manufacturer?
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