Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Huvitz Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
96 daysmedian FDA review time
275 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232143 | Applanation Tonometer HT-5000 | Huvitz Co., Ltd. | 2023-10-23 | 96 | 0 |
| K202097 | Fundus Camera | Huvitz Co., Ltd. | 2021-02-02 | 188 | 0 |
| K191615 | Huvitz Imaging System | Huvitz Co., Ltd. | 2019-07-18 | 30 | 0 |
| K161829 | Huvitz Imaging System | Huvitz Co., Ltd. | 2017-04-06 | 275 | 0 |
| K093639 | SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 | Huvitz Co., Ltd. | 2009-12-03 | 9 | 0 |
| K073190 | SLIT LAMP | Huvitz Co., Ltd. | 2008-01-11 | 59 | 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