Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
GLK · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
358 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121467 | EUROTROL HEMATOCRIT CONTROL | Eurotrol B.V. | 2013-05-10 | 358 | 0 |
| K021924 | MEDICA EASYQC HEMATOCRIT CONTROL | Bionostics, Inc. | 2002-06-24 | 13 | 0 |
| K020618 | AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL | Aalto Scientific, Ltd. | 2002-05-14 | 78 | 0 |
| K964452 | HEMATACHEK | Richmond Diagnostics, Inc. | 1997-02-20 | 106 | 0 |
| K961807 | CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 | Ciba Corning Diagnostics Corp. | 1996-07-26 | 77 | 0 |
| K924926 | MSI-HCT | Medical Specialties, Inc. | 1993-01-07 | 99 | 0 |
| K893562 | A.QC HCT LEVEL 1 AND 2 | Johnson & Johnson Professionals, Inc. | 1989-07-14 | 66 | 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