Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hass Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
330 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260859 | Rosetta SM, Rosetta SP | Hass Corp. | 2026-06-11 | 87 | 0 |
| K202952 | Amber Mill Q Series & Amber Mill Direct Series | Hass Corp. | 2021-08-26 | 330 | 0 |
| K160102 | Amber Mill Series and Amber Press Series | Hass Corp. | 2016-07-14 | 177 | 0 |
| K111573 | MONOBLOC BM SERIES | Hass Corp. | 2011-08-26 | 81 | 0 |
| K102305 | HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTO | Hass Corp. | 2010-12-03 | 109 | 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