Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Carl Zeiss Surgical GmbH — 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) |
|---|---|---|---|---|---|
| K110590 | INTRABEAM NEEDLE APPLICATOR | Carl Zeiss Surgical GmbH | 2012-04-13 | 408 | 0 |
| K100468 | ZEISS INFRARED 800 WITH FLOW 800 OPTION | Carl Zeiss Surgical GmbH | 2010-03-03 | 13 | 0 |
| K090584 | INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS | Carl Zeiss Surgical GmbH | 2009-11-24 | 266 | 4 |
| K051055 | INTRABEAM SYSTEM | Carl Zeiss Surgical GmbH | 2005-05-23 | 27 | 1 |
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