Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Geometric Data, Div. Smithkline Corp. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
125 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841852 | AUTOLYZER 800 | Geometric Data, Div. Smithkline Corp. | 1984-09-05 | 125 | 0 |
| K811534 | HEMASPINNER | Geometric Data, Div. Smithkline Corp. | 1981-08-18 | 78 | 0 |
| K791041 | HEMATRAK ABNORMAL RECOGNITION | Geometric Data, Div. Smithkline Corp. | 1979-09-04 | 91 | 0 |
| K790816 | HEMATRAK MODEL 480 | Geometric Data, Div. Smithkline Corp. | 1979-07-17 | 81 | 0 |
| K791108 | CONTEXT FILTER | Geometric Data, Div. Smithkline Corp. | 1979-07-17 | 33 | 0 |
| K790042 | STAIN, HEMASTAIN RETIC | Geometric Data, Div. Smithkline Corp. | 1979-02-15 | 41 | 0 |
| K780577 | PLATELETS/CU MM | Geometric Data, Div. Smithkline Corp. | 1978-05-19 | 39 | 0 |
| K772139 | RE-CELL SLIDE RECAP | Geometric Data, Div. Smithkline Corp. | 1978-01-05 | 52 | 0 |
| K761207 | HEMATRAK RBC MORPHOLOGY | Geometric Data, Div. Smithkline Corp. | 1977-10-18 | 315 | 0 |
| K770680 | HEMATRAK | Geometric Data, Div. Smithkline Corp. | 1977-07-01 | 81 | 0 |
| K770550 | ATYPIA PROFILE MONITOR | Geometric Data, Div. Smithkline Corp. | 1977-06-17 | 88 | 0 |
| K770701 | HEMATRAK MODEL 125 | Geometric Data, Div. Smithkline Corp. | 1977-06-03 | 46 | 0 |
| K770869 | ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION | Geometric Data, Div. Smithkline Corp. | 1977-06-02 | 20 | 0 |
| K761208 | HEMATRAK MATURITY PROFILE OPTION | Geometric Data, Div. Smithkline Corp. | 1977-02-28 | 83 | 0 |
| K760007 | BLOOD-SMEARING INSTRUMENT (MINIPREP TM) | Geometric Data, Div. Smithkline Corp. | 1976-09-03 | 87 | 0 |
| K760485 | HEMASTAIN FIXATIVE | Geometric Data, Div. Smithkline Corp. | 1976-08-30 | 10 | 0 |
| K760487 | HEMASTAIN PHOSPHATE BUFFER | Geometric Data, Div. Smithkline Corp. | 1976-08-30 | 10 | 0 |
| K760486 | HEMASTAIN WRIGHT STAIN | Geometric Data, Div. Smithkline Corp. | 1976-08-30 | 10 | 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