Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Haag-Streit AG — 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) |
|---|---|---|---|---|---|
| K142423 | EyeSuite Imaging | Haag-Streit AG | 2014-09-10 | 13 | 0 |
| K100202 | SLIT LAMP BO 900, BQ 900, BP900 | Haag-Streit AG | 2010-03-19 | 53 | 0 |
| K082891 | LENSTAR, MODEL LS900 | Haag-Streit AG | 2009-10-20 | 385 | 2 |
| K982057 | BC 900 SLIT LAMP | Haag-Streit AG | 1998-08-14 | 64 | 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