Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kyoto Diagnostics, Inc. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
54 daysmedian FDA review time
80 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K861733 | ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS | Kyoto Diagnostics, Inc. | 1986-07-25 | 80 | 0 |
| K843003 | GLUCOSE AUTO& STAT GA-1120 | Kyoto Diagnostics, Inc. | 1984-09-28 | 60 | 0 |
| K842750 | OSMOTIC PRESSURE AUTO & STAT OM-6010 | Kyoto Diagnostics, Inc. | 1984-08-17 | 35 | 0 |
| K842168 | ATAGO URINE SPECIFIC GRAVITY & SERUM | Kyoto Diagnostics, Inc. | 1984-07-16 | 46 | 0 |
| K841714 | KYOTEST 2V, URINE TEST REAGENT STRIP | Kyoto Diagnostics, Inc. | 1984-05-31 | 37 | 0 |
| K841715 | KYOTEST UK URINE TEST REAGENT STRIP | Kyoto Diagnostics, Inc. | 1984-05-31 | 37 | 0 |
| K841713 | KYOTEST UG URINE TEST REAGENT STRIP | Kyoto Diagnostics, Inc. | 1984-05-31 | 37 | 0 |
| K840827 | KYOTEST 5V | Kyoto Diagnostics, Inc. | 1984-05-14 | 80 | 0 |
| K840828 | KYOTEST 8V | Kyoto Diagnostics, Inc. | 1984-05-14 | 80 | 0 |
| K840996 | URINE ANALYZER SYSTEM | Kyoto Diagnostics, Inc. | 1984-05-01 | 54 | 0 |
| K840829 | KYOTEST UGK | Kyoto Diagnostics, Inc. | 1984-04-19 | 55 | 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