Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PZM — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
267 daysmedian FDA review time
718 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260235 | CellDx-Tissue | Datar Cancer Genetics Private Limited | 2026-05-12 | 106 | 0 |
| K241868 | xR IVD | Tempus AI, Inc. | 2025-09-19 | 449 | 0 |
| K250003 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) | Geneseeq Technology, Inc. | 2025-08-29 | 239 | 0 |
| K210017 | ACTOnco, ACTOnco IVD | Act Genomics | 2022-12-23 | 718 | 0 |
| K202304 | NYU Langone Genome PACT (Genome Profiling of Actionable Canc | Nyu Langone Medical Center | 2021-07-14 | 334 | 0 |
| K192063 | PGDx elio tissue complete | Personal Genome Diagnostics | 2020-04-24 | 267 | 0 |
| K190661 | Omics Core | Nanthealth, Inc. | 2019-11-09 | 240 | 0 |
| DEN170058 | MSK-IMPACT (Integrated Mutation Profiling of Actionable Canc | Memorial Sloan-Kettering Cancer Center | 2017-11-15 | 51 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda