Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Endomagnetics Ltd., — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
123 daysmedian FDA review time
287 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232865 | Magseed Pro Magnetic Marker System | Endomagnetics Ltd., | 2024-06-28 | 287 | 2 |
| K222832 | Sentimag System | Endomagnetics Ltd., | 2023-01-21 | 123 | 0 |
| K173587 | Magseed Magnetic Marker Systtem | Endomagnetics Ltd., | 2018-02-16 | 88 | 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 |
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