Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Heraeus Medical Components, LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191305 | Hereaeus Poseidon Microcatheter | Heraeus Medical Components, LLC | 2019-12-19 | 219 | 0 |
| K191502 | Heraeus Peripheral Guidewire | Heraeus Medical Components, LLC | 2019-11-26 | 173 | 0 |
| K170664 | Odyssey Micro Catheter | Heraeus Medical Components, LLC | 2017-11-09 | 248 | 0 |
| K173052 | Heraeus TMW Guidewire | Heraeus Medical Components, LLC | 2017-10-20 | 22 | 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