Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QTZ — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
256 daysmedian FDA review time
444 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253264 | myAblation Guide (VC10A) | Siemens Healthcare GmbH | 2026-06-16 | 260 | 0 |
| K252947 | HistoSonicsĀ® Planning Tool | HistoSonics, Inc. | 2026-05-29 | 256 | 0 |
| K251931 | BioTraceIO Vision (V1.7) | Techsomed Medical Technologies | 2025-09-08 | 76 | 0 |
| K240796 | myAblation Guide (VB80A) | Siemens Healthcare GmbH | 2024-08-06 | 137 | 0 |
| K240773 | VisAble.IO | Techsomed | 2024-04-15 | 25 | 0 |
| K222222 | Artemis, Artemis TPO, Artemis MX | Eigen | 2023-10-12 | 444 | 0 |
| K222938 | Ablation-fit | R.A.W. S.R.L | 2023-09-12 | 351 | 0 |
| K223639 | VisAble.IO | Techsomed | 2023-08-28 | 266 | 0 |
| K220256 | MIM-Ablation | Mim Software, Inc. | 2022-10-07 | 249 | 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