Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PBY · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
135 daysmedian FDA review time
341 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223682 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pint | Sirius Medical Systems B.V. | 2023-11-09 | 336 | 0 |
| K222643 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pint | Sirius Medical Systems B.V. | 2022-10-19 | 48 | 0 |
| K200734 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pint | Sirius Medical Systems B.V. | 2021-02-24 | 341 | 0 |
| K163667 | RFID Localization System- Localizer Reader, RFID Localizatio | Health Beacons, Inc. | 2017-04-28 | 122 | 0 |
| K163541 | Magseed Magnetic Marker System | Endomagnetics Ltd., | 2017-01-13 | 28 | 0 |
| K153044 | Sentimag System, Sentimark Magnetic Marker Systerm | Endomagnetics Ltd., | 2016-03-02 | 135 | 0 |
| K120804 | CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM | Cianna Medical | 2013-02-04 | 325 | 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