Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
H&abyz Co., Ltd. · 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) |
|---|---|---|---|---|---|
| K251223 | HnX-P1, HnX-PB | H&abyz Co., Ltd. | 2025-08-04 | 105 | 0 |
| K223930 | A1417MCW/A1717MCW/F1417MCW | H&abyz Co., Ltd. | 2023-03-06 | 66 | 0 |
| K213497 | ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) | H&abyz Co., Ltd. | 2021-11-15 | 14 | 0 |
| K203188 | ADD | H&abyz Co., Ltd. | 2021-03-12 | 136 | 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